Job Vacancies at Aspen Pharma Group

Objective: 

• To promote and generate sales on key product portfolios to pharmacies on both ethical and generic ranges. In addition to mentioned objective, the position will also be responsible for building and maintaining strong business relationships with pharmacy decision makers, in order to drive net sales revenue.

KEY RESPONSIBILITIES

Achieve and exceed set sales targets. (Sales vs Budget)

• Constant monitoring and driving of sales from customers, scripting from doctors and sales from pharmacies in order to meet set targets.  Sales to be driven at customer level by affective scientific detailing and use of marketing material.

Plan - Pre-call planning on RepWise and daily

• To be done weekly on Repwise and daily prior to the customer call.  This will ensure that you are prepared for the call. If you have a manager working with you for the day, your pre-call planner must be emailed to the relevant manager, the evening before. Review the available data (Impact Rx, Z-more reports, Shortfall reports, SSD, QlikSense and Swift etc).  

Achieve Call Rate and CPA objectives

• See the required number of customers on a daily basis to achieve call rate and at the correct frequency to achieve call plan adherence.

 Capture daily calls and activities on Rep Wise.

• Calls logged, closed and Comms to be done, or as specified by the business

Conduct Doctor or pharmacy activities in line with compliance and regulatory standards.

• Complete the required number of pharmacy trainings and Doctor/pharmacy activities as required per business and territory requirements

Requirements

Knowledge:

• Proficiency in Microsoft applications
• A sound understanding of the pharmaceutical industry
• Comprehensive understanding of business procedures.

 Skills and Attributes:

• Effective scheduling and attending of appointments and activities with Healthcare practitioners (Doctors & Pharmacies etc) in order to influence sales and meet sales targets.
• Implementing of strategies to drive sales and growth in territory
• Maintain a solid working relationship with customers and colleagues.
• Territory and customer analysis in order to identify gaps and opportunities to be acted upon.
• Excellent analytical skills to review available data
• Clear communication skills both verbally and written.
• Strong capabilities in logical reasoning in order to address and resolve queries and issues
• Influencing and negotiation skills.
• Forward thinker with the ability to work independently as well as to work as a team player.
• Good administrate skills in order to ensure that tasks are completed accurately and timeously.
• Strong work ethic.
• Establishes and maintains positive relationships (mutual trust and respect) with customers and other stakeholders.
• Good product knowledge and the ability to utilise detail material with the correct scientific messaging in order to drive sales

EDUCATION & EXPERIENCE

• Matric
• A valid driver’s license
• Tertiary qualification or certified sales profession certification would be an advantage.
• Proficiency in Microsoft applications
• Minimum 2 or 3 years proven track record in a sales environment

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Overview

• Performs product recipe functions (BOM, routing, master data management, master batch record creation, validation and change management) in MES

Coordinates and supports administrative functions within QS

Responsibilities

• QS coordination and support
• Provide QA IT systems support
• Ensure manufacturing processes, duties and activities are designed according to GMP and regulatory requirements
• Perform process evaluation, including reporting of process and system deficiencies and following up on corrective actions
• Master data management
• Define and manage critical data relating to quality
• Ensure adherence to product master data standards Master batch record (MBR) creation and validation
• Create new item IDs on the ERP
• Create and maintain precise, detailed and compliant manufacturing instruction/ description documentation on the system
• Check that MBRs contain all pharmaceutically relevant data, including input material list, valid SOPs, detailed work instructions, process data/ steps (e.g. IPCs, CPPs, CQAs)
• Ensure that MBRs are GMP compliant
• Ensure proper MBR change controls in process compliance Procedure and document compliance
• Align engineering and QA policies and configure system for cleaning and hold times, maintenance, calibration, and equipment tares
• Implement quality manuals and policies
• Conceptualise, initiate and author SOPs and process documents Identify, process and store records and review output documents
• Conduct reviews of protocols for product launches Audits and reporting
• Conduct root cause analysis and risk assessments and report
• Participate in QMS monthly and annual reviews
• Conduct and report on statutory external (regulatory) audits Planning and operational support
• Provide technical and operational input during drafting of quality plans and procedures specific to unit
• Request, allocate and monitor the use of MES related assets and resources for the fulfilment of work objectives
• Stay up to date on developments, trends, legislation and regulations
• Provide information for reports, as required by superior

Requirements

• Requirements Background/experience
• Bachelor’s degree (B Pharm) with 4-6 years’ related work experience
• Pharmaceutical manufacturing experience
• Extensive experience working with compliance procedures and administrative process automation Specific job skills
• Good knowledge of local registrations and regulations and of international regulations/guidelines concerning GDP/GMP, QA 
• Advanced understanding of the pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Excellent computer/ IT system administration skills Competencies
• Information Gathering
• Interrogating Information
• Offering Insights
• Endorsing Quality Standards Accountability and Decision Rights
• Demonstrate initiative and apply advanced concepts
• Exercise interpersonal, communication, training and problem solving skills to optimise team performance integrate resources for an area
• Escalate highly complex problems or out-of-policy issues Decisions relating to:
• Technical approach for project components, often in ambiguous situations, requiring advanced analytical skill, training/ education
• Establishing own work priorities and timelines Interpretation of policies, standards, requirements and approaches

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Overview

• Maintain and calibrate lab instruments according to SOPs and maintenance schedules
• Facilitate the repair of lab equipment
• Verify that equipment produce accurate and reliable results

 Key Responsibilities

• Equipment Maintenance and Calibration
• Maintain the lab calibration schedule
• Perform calibration and preventative maintenance of lab equipment according to SOPs and schedules Repair or outsource repairs of faulty lab equipment
• Monitor calibration of equipment by external service providers
• Evaluate calibration failures and instrument breakdowns, and impact on lab results
• Report calibration deviations and equipment/ instrument failures to management
• Complete OOC documentation and establish and communicate risk of using OOS equipment Recommend changes to maintenance and calibration procedures
• Develop, review and implement SOPs for equipment used for calibration
• Participate in audits of equipment as required
• Maintain Good Lab Practice Customer Service / Stakeholder Management
• Propose and develop methods for improving customer service
• Update internal and external customers on progress of maintenance/ repair queries
• Manage lab maintenance requests
• Asset/ Resource Coordination
• Determine and request resources/ assets for the fulfilment of work; and monitor its use Reporting and Record-Keeping
• Monitor and trend adherence to schedule ensuring customer requirements met
• Document and file data according to SOPs and regulation
• Gather information required for reports
• Update records and systems as required

Requirements
Requirements Background/experience

• Trade Tested Artisan with 4-6 years’ related experience
• Laboratory experience Specific job skills
• Comprehensive understanding of pharmaceutical testing methods, equipment calibration, maintenance and repairs 
• Understanding of pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives
• Physically capable of lifting/ moving heavy equipment Competencie
• Meeting Deadlines
• Following Procedures
• Maintaining Accuracy
• Customer Awareness Accountability and Decision Rights
• Demonstrate initiative and apply advanced concepts
• Exercise interpersonal, communication, training and problem solving skills to optimise team performance integrate resources for an area
• Escalate highly complex problems or out-of-policy issues

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Description

• Perform QC and stability tests on raw materials, in-process and finished products, components, and water to ensure quality and compliance.
• Review compliance of products to GMP, quality standards, and product specifications.
• Provide services according to Production plan.

Requirements

Planning and Operational Support

• Optimise and facilitate implementation of current processes
• Propose changes or improvements to processes, tools, and techniques.

Test Preparation

• Prepare and analyse samples according to SOPs.
• Prepare and operate laboratory equipment according to SOPs.
• Perform calibration checks on equipment according to calibration procedure, to ensure accurate results.
• Prepare reagents and solutions for testing.
• Maintain good housekeeping.

Testing

• Perform HPLC/GC analysis using MOA
• Perform routine analysis on in-process and final products, raw materials, and components.
• Perform routine stability tests such as related substances, assay, and dissolution to assess quality of product.
• Perform daily and weekly water testing according to SOP.
• Support testing for OOS investigations to establish any systematic issues in process or testing.
• Handle problems efficiently according to quality policy
• Report feedback on services or outputs regularly to customers
• Check HPLC/GC runs regularly during the shift.
• Provide internal customers with accurate HPLC/GC results.
• Propose, develop, and update methods for improving customer service.
• Check, document, and report operational output against actuals.
• Communicate deviations for production and process improvements.
• Utilise technology as per qualification requirements.

Reporting and Record-Keeping

• Document and store data according to SOPs and regulation
• Consolidate information for reports on weekly/ monthly basis.
• Analyse consolidated data and provide recommendations.
• Record, interpret and report testing results to management, including OOS results.

Skills Required

Background/experience

• National Diploma in Analytical Chemistry with 2+ years’ experience
• Laboratory experience

Specific job skills

• Advanced understanding of pharmaceutical testing methods
• Understanding of pharmaceutical manufacturing and corrective action programs
• Knowledge of Millennium Software (HPLC) and GC Software
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes, and objectives.

Competencies

• Interrogating Information
• Meeting Deadlines
• Following Procedures
• Maintaining Accuracy
• Customer Awareness

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Description

• Perform validation exercises of production and lab equipment, utilities, packaging, and processes to ensure specific standard of compliance is met.

Requirements

Responsibilities

Planning and Operational Support

• Act as a technical/ subject matter resource
• Facilitate implementation of current processes
• Identify gaps in current policies and procedures.
• Provide input into changes or improvements to processes, tools, and techniques.

Validation

• Perform validation exercises in compliance with GMP standards and validation schedules.
• Maintain compliant status of equipment and processes.

Qualification

• Perform the relevant operational qualification protocols as per SOP to ensure new equipment / utilities / packaging function as per intended use.
• Perform the relevant performance qualification protocols as per SOP to ensure new equipment / utilities / packaging function as intended over time and within limits.
• Investigate and report OOE results and perform re-tests.
• Participate in change control assessments to ensure compliant status of affected equipment is not compromised.
• Conduct routine inspections of equipment and utilities to identify any deficiencies and ensure quality standards are being adhered to
• Ensure documents and procedures to operate and maintain equipment are in place.

Requalification

• Assess and recommend re-qualification of equipment and utilities as appropriate as per Protocol
• Prepare and perform re-qualification of equipment and utilities as per SOP.

Reporting and Record-Keeping

• Compile, maintain and update validation documentation as per SOP and QMS
• Generate validation reports on a weekly/ monthly basis.

Skills Required

Background/experience

• National Certification (N4-N6) or Trade Tested Artisan with 2-4 years’ related experience
• degree or equivalent qualification in Science (Chemistry, Microbiology) or Engineering (Chemical, Pharmaceutical or Process), or equivalent industry experience
• Aseptic pharmaceutical manufacturing process and automated packing experience

Specific job skills

• Comprehensive knowledge in the application of Qualification and Validation principles pertaining to aseptically filled products.
• Knowledge of control and instrumentation systems, electrical systems and reading of electrical diagrams
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes, and objectives.

Competencies

• Interrogating information
• Maintaining accuracy
• Following procedures
• Technical writing

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JOB PURPOSE

Shape the talent acquisition (TA)n strategy to align to the Groups short-medium term business goals, to attract and secure talent for Professional, Senior and C- Suite vacancies, across the Global Micro and Macro Landscape, whilst guiding the achievement of the Groups Equity, Diversity and Inclusion strategy and South African Transformation Objectives. Help grow the talent by finding and nurturing the most suitable talent to contribute to Aspen’s future success.

Provide a transactional end to end recruitment service for Professional, Senior and Top Management Positions – i.e., Paterson DU, E and F Bands that seeks to build a diverse and inclusive workplace, where candidates have the right skill set and culture fit to drive productivity and efficiencies. Define and guide tactical talent acquisition strategies (including private and confidential searches) in collaboration with the Global/Regional Heads of Human Capital (HC), Business Unit Heads, and other key stakeholders for Mission Critical, Key Person and Scarce Skills. This role is accountable for the design, roll out, monitoring and evaluation of Group wide TA Tools, Systems and Processes

 

KEY PERFORMANCE AREAS

Talent Acquisition Strategy, Policy and Governance

• Evaluate and provide input into the Global Talent Acquisition strategy, focusing on building external talent pipelines for Professional, Senior and C- Suite (DU, E and F bands) within the pharmaceutical sector across all areas of the value chain
• Work with Talent Management to build internal talent pipelines
• Develop the Recruitment and Selection Group policies and procedures affecting Talent Acquisition and contribute to the discussion of Recruitment policies affecting the whole organisation
• Develop company’s policy for talent benchmarking, talent assessment and interviewing guidelines
• Develop Talent Acquisition SOP’s, Guidelines, Toolkits and Templates to create standardised seamless way of work
• Implement the Talent acquisition strategy across the business
• Responsible for recruiting external pipeline, meeting recruiting targets and putting together reports on talent acquisition metrics
• Design and implement appropriate sourcing strategies for different skills in the business
• Contribute to on-boarding processes
• Enhance careers portal promoting hard to fill careers and promoting Aspen as an employer of choice
• Manage respective candidate pools to ensure qualified candidates remain engaged in current or future opportunities
• Provide external marketplace information to Recruiting Leadership in order to attract diverse talent, build diverse talent pools and mitigate bias in hiring decisions by the design and implementation of training programmes, interview guides, recruitment processes
• Upskill Business Units, Senior and Top Managers, and Line management, on hiring and selection processes, aligning to the latest trends and best practice
• Participate in recruitment related projects and/or initiatives within or outside the team
• Communicate with internal and external stakeholders providing recruitment status report details on the progress made on a project
• Proactively seek market intelligence to gain competitive advantage in attraction, assessment, and sourcing methodologies
• Suggest new ideas for improving talent acquisition activities
• Research talent acquisition trends in the staffing industry
• Work with Group HR Shared Services to implement transformation processes
• Provide external marketplace information to Recruiting Leadership
• Responsible for Group, International and Regional Strategic sourcing, and external talent mapping projects
• Lead and direct the sourcing discussion with Executives, International and Regional Heads
• Advise and recommend cost of sourcing and Prepare cost of sourcing when needed
• Accountable for the strategic talent sourcing planning and provide input associated with external talent acquisition planning and pipelining based on collaboration and consolidation of internal and external stakeholder inputs
• Advise on cost of Talent Acquisition decisions impacting profitability and/or approach of work
• Collaborate with Regional and International HR Heads for information related to acquiring Talent Acquisition
• Finalise, negotiate and present offer to selected Hirer
• Handover and transfer complete file to Regional/International HR Head to produce Employment Contract and support onboarding

Strategic Sourcing and External Talent Mapping Recruitment for Group 

• Create and implement end-to-end candidate hiring processes to ensure a positive experience
• Review employment applications and background check reports
• Design, develop and implement recruitment strategies and campaigns, and management thereof by designing and managing the recruitment and selection processes (resume screening, screening calls, interviews etc.) for allocated roles
• Ensure adherence to internal control check points in line with audit requirements
• Provide input to market salaries, salary package negotiation and benchmark data
• Review recruitment files for completeness
• Oversee talent acquisition goal achievement and corrective action as required
• Responsible for identifying and implementing appropriate recruitment software / assessment tools
• Develop Training Methodology to support Global Roll Outs of TA systems

Offer management

• Working with COEs and Business unit Human Capital leads to put together offers, reviewing pay documents and preparing pay comparison worksheet
• Present and negotiate the offers up to DU, E and F band, in collaboration with the BU Human Capital lead

Assessments

• Review assessment reports and provide feedback to hiring manager, in collaboration with Business unit Human Capital leads
• Identify, advise and determine assessments to be conducted from a standard battery of assessments for Professional, Senior and C- Suite Regionally and Internationally

Stakeholder engagement

• Communicate regularly with Human capital department to get a clear view of their hiring needs and organizational goals.
• Establish and maintain appropriate networks with relevant professional bodies
• Serve as brand ambassador at various events, like career fairs or on-campus recruiting events, representing the company both internally and externally to build relationships with candidate communities
• Form close relationships with hiring managers to ensure clear candidate/interviewer expectations and align on process and timelines
• Recommend and provide input on the efficiency and effectiveness of service providers
• Build strong relationships with external recruitment agencies and executive search firms as appropriate
• Network, collaborate, build and maintain relationships with external and internal stakeholders with medium- and long-term implications
• Consult and collaborate with business stakeholders on hiring best practices, diverse acquisition approaches, and selection techniques
• Upskill Business Units, Senior and Top Managers and Line Management on hiring and selection processes, aligning to the latest trends and best practice
• Work closely with the communication department to develop creative ways for addressing talent acquisition challenges

Vendor management

• Negotiate vendor SLA’s and Costs and put together approved vendor list, whilst ensuring appropriate accreditation
• Put together a proposal for global executive search panel and preferred supplier list
• Research, develop and implement Group guidelines, criteria, and principles for selecting best Global Talent Acquisition Executive Search Companies and Specialist Recruitment Agencies develop and Maintain Global SLA database to ensure economies of scale and understanding of Aspen Culture and Business Need
• Accountable for negotiating and managing recruitment vendor agreements with worldwide external stakeholders
• Work with Group Legal to manage and negotiate Global, C-Suite and Executive Search Firms and specialist recruitment agency contracts to ensure they are legally binding and aligned to legislative requirements
• Maintain Global SLA and Manage database of approved list to ensure economies of scale and understanding of Aspen Culture and Business need
• Accountable for negotiating and managing recruitment vendor agreements with worldwide external stakeholders, aligned to principles and criteria
• Provide vendor cost for Job Boards, Social Media agreements, Application Tracking Systems and related Talent Acquisition spend for budgetary purposes

Accountability / Budgetary Reporting

• Manage the recruitment spend
• Provide ROI of tools and subscriptions
• Create monthly reports on key talent acquisition metrics
• Provide input into the talent acquisition metrics to evaluate recruitment practices
• Collaborate with broader teams to determine talent acquisition metrics and performance indicators
• Report against talent acquisition metrics and in service of continuous improvement initiatives
• Provide analysis of information with recommendations for decision-making at higher levels
• Recruitment status reports
• Provide input into the development of the Group Talent Acquisition financial plan
• Provide ROI of Group tools and subscriptions
• Oversee the management of accurate record keeping of all recruitment related aspects and reporting as required

People and Process Management

• Manage, develop and motivate staff within Group Talent Acquisition
• Respond and disseminate external vacancy queries to relevant BU’s regionally and internationally

Compliance & Audit

• Compile and align advertising communication to compliance and statutory requirements                                                    
• Implement and update data management policies and procedure
• Ensure recruitment policies and guidelines are adhered to includes general compliance issues such as ensuring adherence to site and group policies and procedures, information security, data management
• Monitor and correct compliance with legislation, policies, and procedures, by engaging with activities, reviewing documentation, and discussing processes.
• Manage updates and ensure alignment of Recruitment Governance and Compliance
• Establish and maintain a consistent and effective Recruitment process aligned to external and internal audit requirement.
• Responsible and accountable for internal control check points in line with audit requirement

TA Projects and Assignments

• Lead” Private & Confidential” search projects and provide stakeholder communications directly to C-Suite and Regional and International Head
• Responsible for Group Talent Acquisition projects and assignments related to costs, hiring methods, planning, systems and integration
• Participate in recruitment related projects and/or assignments within or outside the team

Requirements

EDUCATIONAL QUALIFICATIONS & EXPERIENCE

• Bachelor’s degree (or equivalent) in human resources management or similar field
• Matric Certification
• 10 years’ recruitment/talent acquisition experience working for an agency or in house recruitment function, including supervisory or managerial experience within a global context

SPECIFIC EXPERIENCE, KNOWLEDGE AND REGISTRATIONS 

• 5 years specialised pharmaceutical manufacturing, corporate and commercial recruitment experience.
• Knowledge of APSO code of ethics

WORK-SPECIFIC SKILLS & EXPOSURE

• Talent Acquisition experience working at Group level within a Global Corporate Head Office
• Cross-border recruitment practices with local in-country cultural awareness
• Negotiating fees for Private and confidential C-Suite and Executive roles both locally and internationally.
• Advanced Global Talent Acquisition sourcing techniques, Recruitment and Selection processes (including Application Management and Behavioral/Competency Based Interviewing
• Execution of talent acquisition strategies and plans at Group level aligned to the Groups medium- and long-term strategic goals
• Global Stakeholder management
• Project Management
•  Hands-on experience with full-cycle recruiting using various interview techniques and evaluation methods
• Assess, design, implement and manage global and local recruitment strategies and campaigns.
• Planning and organising skills
• Attention to detail
• Advanced numerical skills
• Excellent communication skills, written and verbal

Technical competencies & skills

Skills and attributes:

• Ability to devise sourcing strategies for potential applicants
• Excellent interpersonal and communication skills for working closely with others across various departments and at all levels of the organisation
• Dynamic and resilient, kind, open-minded personality with the proven capability to advise and motivate regional and international stakeholders on all levels
• Strong negotiation, influencing, facilitation, project management and business partnering skills.
• Independent and self-directed individual that can drive execution
• Able to work in a high performance and deadline driven environment.
• Present a positive and professional image of the group talent acquisition team
• Integrity and must be able to maintain confidentiality
• Recruitment Metric reporting
• Database and information management skills
• Ability to upskill stakeholders on Recruitment and Selection Policy, Process and Tools
• Understanding of job evaluation and job design

Knowledge:

• Proficiency with social media, CV databases, and professional networks
• Experience in using LinkedIn Talent Solutions to proactively source candidates
• Proficiency in documenting processes and keeping up with industry trends
• Deep knowledge of talent acquisition – related best practice, trends and innovations, systems, tools and recruitment – related continuous improvement initiatives
• Understanding of remuneration and benefits structuring
• In South African - Labour Relations Act, Employee Equity Act and other labour legislation
• Global Application Tracking Systems
• In-house and External Recruitment processes and best practice
• Knowledge of Applicant Tracking Systems (ATSs)
• Social Medial Platforms and Job boards
• Pharmaceutical Manufacturing industry knowledge

Aspen competencies 

Business

• Performance Driven
• Accountability/ Ownership

People

• Performance Driven
• Accountability/ Ownership

Self

• Performance Driven
• Accountability/ Ownership

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Overview

• Implement after-market compliance systems and quality procedures, standards and specifications Identify and provide solutions to systematic issues Create and review APQRs and PQRs  Deal with complaints, recalls and CAPAs

Responsibilities

Process improvement and support

• Initiate, coordinate, perform and follow up on internal audits
• Provide support during external GMP audits by regulatory and other bodies and perform audit follow-up
• Review validation protocols and reports
• Review GMP-relevant technical/ engineering documentation
• Review and approve event handling and change control
• Compile and maintain SOPs
• Review and sign off change requests and validation documents

APQRs and PQRs

• Perform APQR and PQR processes/ systems
• Review compiled APQRs and PQRs  
• Compile APQRs and PQRs if necessary Provide input into product reviews as required by health authorities
• Engage with relevant departments to address recommendations and outstanding information

Complaint resolution

• Handle customer complaints, queries and adverse drug reactions and related investigations
• Conduct complaint intake, triage and investigation
• Handle returns and recalls, as required Interact with health authorities, where required

Correction and prevention

• Initiate CAPAs and follow up with relevant departments related to Events, Audits, Self-inspections, Complaints and PQRs
• Review and approve event handling and change control

Reporting and analysis

• Categorise complaints, conduct trend analyses and report
• Conduct root cause analysis and risk assessment and report

Planning and operational support

• Provide technical and operational input during drafting of plans and procedures specific to unit
•  Request, allocate and monitor the use of assets and resources for the fulfilment of work objectives
• Stay up to date on developments, trends, legislation and regulations Provide information for reports, as required by superior

Requirements

 Background/experience

• Bachelor’s degree (B Pharm) with 4-6 years’ related work experience, or Post Graduate Degree/ Diploma with 2-4 years’ related work experience
• Pharmaceutical manufacturing experience 

Specific job skills

• Protocol and technical report writing skills
• Good knowledge of local registrations and regulations and of international regulations/guidelines concerning GDP/GMP, QA
• Advanced understanding of the pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Information Gathering
• Interrogating Information
• Managing Performance
• Offering Insights
• Endorsing Quality Standards

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Overview

• Compilation of APQRs and PQRs  
• Handling of complaints and recalls processes

Responsibilities

Process improvement and support

• Carry out internal audit activities
• Provide support during external GMP audits by regulatory and other bodies
• Maintain SOPs

APQRs and PQRs

• Compile APQRs and PQRs
• Conduct and maintain accurate records of product reviews, as required by health authorities
• Communicate APQR and PQR requirements, recommendations and processes with relevant departments

Complaint resolution

• Handle customer complaints, queries and adverse drug reactions and related investigations
• Conduct complaint intake, triage and investigation  
• Assist in the handling of returns and recalls, as required

Reporting and analysis

• Conduct preliminary trend analyses and report
• Conduct preliminary root cause analysis and risk assessments and report
• Consolidate information for reports specific to area of responsibility

Planning and procedures

• Plan for and prioritise own tasks and responsibilities, within standards and procedures, to fulfil work requirements
• Determine resource needs of own area of work
•  Optimise current processes

Requirements
Background/experience

• 2 to 4 years’ related work experience
• Learnership and registered PMA

Specific job skills

• Report writing skills
• Working knowledge of local registrations and regulations and of international regulations/guidelines concerning GDP/GMP, QA
• Understanding of the pharmaceutical manufacturing and corrective action programs, pharmaceutical standards and compliance requirements

Competencies

• Customer Awareness  
• Following Procedures Interrogating Information
•  Organisational Citizenship

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Overview

• Monitor manufacturing compliance to GMP and statutory requirements
• Monitor adherence to guidelines, procedures, and document controls
• Related support and administrative tasks

Responsibilities
Inspections and Verifications

• Perform visual inspections of rooms, machine parts and equipment
• Verify that rooms and equipment are certified clean as per SOP
• Verify scale and measuring equipment performance and daily calibration as per SOPs, protocols and schedules
• Verify daily sampling, dispensing of materials and its mass/ volume
• Perform housekeeping of rooms and equipment

Line & Production processing

• Perform line sign-on and closure
• Check and authorise packaging line clearance
• Order and maintain substance materials
• Perform batch reconciliations to product specifications and quality
• Monitor production process in line with standards and specifications

Process and system improvements

• Manage change control programs and deviations/ concessions in line with SOPs, standards and product quality and specifications
• Manage and resolve customer complaints
• Optimise processes and identify gaps in policies/ procedures

Compliance & Auditing

• Conduct shift GMP checks and ensure continued compliance
• Conduct environmental checks and check expiry dates of agents
• Verify good document practice as per SOP and regulation
• Verify the identity of bulk product and printed packaging materials, and conduct intermix checks to assess uniformity
• Verify IPCs are in line with product quality and specifications
• Check preliminary batch records
• Audit logbooks and systems

Troubleshooting

• Investigate deviations and concessions and assess risk
• Raise deviations and implement corrective action
• Raise maintenance notifications as and when required

Training and technical expertise

• Train new PMAs on SOPs
• Identify refresher or awareness training needs
• Administration & Record keeping
• Complete batch records and labels
• Complete deviation forms as required
• Query documents and sign off declarations
• Perform and verify calculations in BMR
• Maintain and update records and systems as required

Requirements
Background/experiencePost Basic registration as Pharmacist Assistant with Pharmacy Council

• 1-3 years’ Pharmacist Assistant experience
• Pharmaceutical manufacturing experience advantageous

Specific job skills

• Basic technical knowledge of pharmaceutical manufacturing, standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Interrogating information
• Meeting deadline
• Finalising outputs
• Maintaining accuracy

Accountability and Decision Rights

• Timely and accurate performance of responsibilities for a single technical area or group of closely related tasks, under supervision
• Learn and implement policies, procedures, quality and compliance standards
• Recognise and resolve basic, routine or common/ repetitive problems
• Seek assistance on complex issues and referring non-prescribed matters
• Stay up to date on legislation and industry regulations

Decisions relating to:

• Own work, within limited, defined parameters
• Prioritisation of basic tasks, with clear guidance

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Overview

Strategic and tactical role in the digital technology organisation and is accountable, in the domain of this position, to manage the provisioning and support of reliable secure software applications and services which support business capabilities and are easily re-used, maintained and updated to meet current and future organisational needs.  Responsibilities include stakeholder identification and relationship management, application life-cycle management, requirements management, business process definition, content authoring and user training, investigation of operational issues, problems, measuring and managing related service contract performance and finding new opportunities in effective business solutions through improvements in aspects of business operations and business systems.

 

Responsibilities

 

Stakeholder management

• Identify stakeholders for the IT services provided within domain of this position, to engage, manage and monitor the relationship and stakeholder communications, to agree on mutually beneficial outcomes and getting commitment to action through consultation
• Deals with problems and issues, managing resolutions, corrective actions, lessons learned, and the collection and dissemination of relevant information.
• Implements stakeholder engagement/communications plan. Collects and uses feedback from customers and stakeholders to help measure the effectiveness of stakeholder management.
• Helps develop and enhance customer and stakeholder relationships.
• Skills: Relationships and Engagement – Stakeholder Relationship Management (Level 4 – Enable)
• To align the technology strategy for the IT services provided within the domain of this position with the business mission, strategy, and processes and documenting this using architectural models while identifying and assessing new and emerging technologies, products, services, methods and techniques
• Interpreting business goals and drivers and translating business strategies and objectives, assessing current capabilities and identifying required changes in capabilities to achieve objectives
• Contributing to creating and reviewing systems capability strategy, reports and technology roadmaps and the sharing of knowledge and insights
• Supports monitoring of the external environment and assessment of emerging technologies
• Develops models and plans to drive business efficiency taking advantage of opportunities to improve performance

Business Process Management

• Define, evaluate and describe business processes, identify change options, and evaluate the financial, technical and business feasibility within the domain of this position
• Understanding the purpose and benefits of modelling using established techniques, as directed, to model simple subject areas within the domain of this position
• Describing the interrelationships between people, organisation, service, process, data, information, technology and the external environment in iterations of architectural models and views
• Determining requirements for and specifying effective business processes, through improvements in technology, information, or data practices, organisation, roles, procedures and equipment.
• Ensuring defined models are aligned with the business vision, mission, objectives and strategy by engaging with relevant stakeholders and specialists and evaluating for financial, technical and business feasibility
• Employ standard techniques to get information required for feasibility assessment and support identification of tangible costs and benefits in development of business cases

Customer Requirements

• To manage the business requirements within the domain of this position throughout the entire delivery and operational life cycle
• Eliciting and documenting functional and non-functional requirements
• Ensuring customer requirements are accurately reflected
• Review and validating these requirements for errors, omissions, and any constraints, and negotiating trade-offs that are acceptable to key stakeholders within budgetary, technical, regulatory and other constraints

Knowledge sharing

• Controls, monitors, and evaluates content to ensure quality, consistency and accessibility of messages and optimal use of chosen media. Understands and manages risks associated with publishing content.  Moderates content and ensures content can be re-purposed appropriately.  Reviews work of others and takes responsibility for ensuring appropriateness
• Systematically capturing, sharing, developing and exploiting the collective knowledge of the organisation
• Supporting a knowledge sharing culture to drive the successful adoption of technology solutions
• Facilitating internal and external collaboration and communications
• Establishing and supporting Centers of Excellence
• Capturing, organising and developing information and knowledge from employees, customers and external partners
• Produce knowledge base articles that are accurate, current, relevant and easily understood by the intended audience.
• Clarifies detailed content requirements with customers and representatives of the intended audience
• Designs, creates, controls and evaluates moderately complex subject matter.
• Makes informed decisions about the best way to present information to an audience.
• Contributes to knowledge management systems to meet business needs

Service Delivery

• Deliver management, technical and administrative services to support and maintain the applications and implement security controls and security management strategies within the domain of this position
• Ensures that all requests for support are dealt with according to set standards and procedures
• Drafts and maintains procedures and documentation for applications support
• Manages application enhancements to improve business performance
• Monitoring performance of applications
• Advises on application security, licensing, upgrades, backups, and disaster recovery needs
• Adherence to established safety, security and quality standards
• Authorises and monitors access to applications and investigates unauthorized access
• Defining and reviewing access rights and privileges and the application and operation of elementary physical, procedural and technical security controls
• Maintain the validated state of the IT systems in alignment with Computer System Validation (CSV) policies and procedures
• Contributes to / leads the successful delivery of IT Projects to implement, change, test and/or upgrade the relevant IT systems

SLA Management

• To obtain formal confirmation that IT service acceptance criteria have been met, agreeing targets for service levels and assessing, monitoring, and managing the delivery of IT services against the targets, including the contractual performance objectives (cost effectiveness, efficiency and service quality) of domain specific IT products and services as provided by suppliers
• Engages with delivery teams to confirm that products developed meet the service acceptance criteria, including functionality, operational support, performance, safety, security and quality requirements
• Negotiates, implements and monitors service level agreements and ensures the service provider is ready to operate the new service when it has been deployed
• Monitors and logs the actual service provided, compared to that required by service level agreements
• Identifies opportunities to improve service delivery / Continuous Service Improvement (CSI)
• Acts as a routine contact point between the organisation and suppliers concerning contract management.
• Supports the collection of contract performance data and creates standard reports on contract performance
• Collects supplier performance data and investigates problems
• Monitors and reports on supplier performance, customer satisfaction, adherence to security requirements and market intelligence and validates that suppliers' performance is in accordance with contract terms.
• Manages performance and risks across multiple suppliers (internal and external) using a set of agreed metrics
• Engages proactively and collaboratively with suppliers to resolve incidents, problems, or unsatisfactory performance

Incident Management

• To coordinate responses to reported incidents, minimising the negative impacts and restoring service as quickly as possible.  Managing the life cycle of all problems that have occurred or could occur in delivering a service.  Assessing risks associated with proposed changes and ensuring changes to products, services or systems are controlled and coordinated.
• Ensure that incidents are handled according to agreed procedures to investigate causes, seek resolution and escalate when required
• Monitors resolution activity and facilitates recovery of processes
• Informs users, customers and key stakeholders of progress towards service restoration
• Ensure user feedback is captured and analysed to inform future decisions
• Initiate and monitor actions to investigate and resolve problems (proactively and reactively) in systems, processes and services, determine problem fixes and remedies
• Collaborate with others to implement agreed remedies and preventative measures and support analysis of patterns and trends to improve problem management processes
• Assess, analyze, develop and implement changes based on requests for change including risk assessment and mitigation, document version management and methods to report on the lifecycle of change requests

Project Management

• Delivering agreed outcomes from projects using appropriate management techniques, collaboration, leadership and governance.
• Defines, documents and executes small projects or sub-projects.
• Works alone or with a small team actively participating in all phases of the project. Applies appropriate project management methods and tools. Identifies, assesses and manages risks effectively.
• Agrees project approach with stakeholders and prepares realistic project plans (including scope, schedule, quality, risk and communication plans). Tracks activities against the project schedule, managing stakeholder involvement as appropriate.
• Monitors costs, times, quality and resources used takes action where these exceed agreed tolerances.

Training and Developmemt

• To provide guidance or training to users — including enhanced levels of support following new/updated software releases – through structured curricula, transferring of knowledge, developing skills and changing behaviours using a range of techniques, resources and media
• Contributes to delivery of aspects of user curricula e.g. end user training content creation and applies good practice in learning content design, development and delivery
• Performs a range of learning activities to support the delivery of learning objectives through a range of techniques, resources and media including — but not limited to — face-to-face learning, e-learning, on-line virtual environments, field-work and projects, self-assessment, peer-assisted learning, simulation
• Assists with maintaining user competence through delivery of training by observing learners perform practical activities and work, and providing assistance within routine enquiries and escalation where needed
• Assists with hypercare and user adoption support following new/updated software releases

GxP Compliance

• Perform all duties in compliance with the relevant GxP and cyber security guidelines, standards, polices and procedures
• Ensuring compliance with relevant guidelines and legislation through adherence to defined Standard Operating Procedures and other ways of working
• Identify gaps in procedural documentation and suggest improvements where required
• Monitoring violations of security policies, analysing relevant logs, alerts and events
• Responding to incidents according to procedures and maintaining the related security records and documentation

Requirements

Background/experience

• Tertiary Qualification in IT or related Business qualification
• Current industry certification (ITIL, TOGAF, GXP, etc.)
• Formal Business Analyst qualification advantageous
• Business Process Management Methodology (BPM / BPMN 2.0, SDLC, etc.)
• Enterprise Architecture (TOGAF, Archimate, etc.) and project / implementation Methodologies (PRINCE II, PMBOK, Agile, etc.) will be an advantage
• 4 – 7 years Business Experience within the specific domains
• 2 – 5 years IT Functional Support in Pharma or equivalent experience

Specific job skills

• Experience managing internal customer relationships
• Experience and sound knowledge of business processes, quality management and customer support practices and improvement practices
• Experience leading and influencing customers and matching needs to solutions

Competencies

• Create the future
• Performance Driven
• Accountability/ Ownership        
• Communicate Effectively
• Dealing with ambiguity Embrace Change          
• Contribute Special Expertise
• Take Action with Integrity

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BASIC JOB FUNCTIONS (Brief Summary):

• To become conversant in the operation of production equipment/machines according to set procedures and work instructions.
• Understand and comply with all relevant SOP’s and work instructions.
• To follow instructions as guided by either the team leader or supervisor.
• Performs regular housekeeping duties to ensure a clean and healthy work environment according to current good manufacturing practices (cGMP) requirements.
• Understand and comply with relevant health, safety, and environmental procedures whilst performing his/her duties.
• Execute daily tasks and work instructions according to the relevant SOP's.
• Ensure that all checks, logbooks, and documentation are completed and signed as per relevant SOP’s.
• Identify and report on operational problems/issues out of specification.
• Ensure the discarding of waste according to the relevant SOP’s.
• Ensures that shift checks on machines, cubicles, scales, and overall cleanliness are conducted.
• Perform routine strip-down, assembly, settings, and operation of equipment/tools according to SOP.
• Perform final major settings during handover (batch-to-batch/product-to-product) as per the relevant SOP.
• Participate in face-to-face shift handover as per SOP.
• Complete all records and reports timeously and accurately as described in the relevant SOP's, protocols, and associated documentation.
• Comply with GMP requirements as outlined by Company SOP's and written instructions in all tasks and activities.
• Ensure that products are stored according to the required SOP's and documentation.
• Ensure all sections within the department maintain compliance with company GMP standards.

PERSONAL ATTRIBUTES (Brief Summary):

• Must be able to work under pressure and be part of a team or independently.
• Good organizational skills with an honest and trustworthy approach.
• Good timekeeping with sober habits and willingness to work shifts and overtime as operationally required.
• Good interpersonal skills.
• Good communication skills (written and verbal).
• Attention to detail.

Requirements

JOB REQUIREMENTS:

• Minimum educational qualification Matric /Grade 12 with mathematics and Science/Biology with a pass in both instances
• and/or equivalent qualification as per national qualification framework levels - SAQA.
• Shortlisted candidates will be invited for language and numerical assessments.
• Must have an aptitude for process understanding and working with hands.   
• Must have the ability to be trained and of good health (intake medical examination will be done as a condition of appointment).
• Previous operator experience in a manufacturing plant would be advantageous but not a requirement.