Current Opportunities at Aspen Pharma Group

Overview

• Monitor manufacturing compliance to GMP and statutory requirements
• Monitor adherence to guidelines, procedures, and document controls
• Deliver expected productivity targets as per business requirements
• Related administrative tasks
• Serve as back up to Team Leader on shift

Requirements

• Responsibilities Planning and Procedures
• Plan and prioritise daily, weekly and monthly activities
• Determine, request and use resources/ assets optimally Inspections and Verifications
• Verify schedule 5 products Verify certified clean status of rooms and equipment
• Verify, review and approve verification of measuring equipment performance, calibrations and sampling, and dispensing of materials Line & Production processing
• Perform, review and approve line sign-on’s, closures and clearance authorisations
• Perform, review and approve batch reconciliations to product specifications and quality
• Ensure production process adherence to standards and specifications Process and system improvements
• Manage, review and approve change control programs and deviations/ concessions comply to standards and specifications
• Manage and resolve customer complaints
• Optimise processes and identify gaps in policies/ procedures
• Drive CAPA investigations in area of focus Compliance & Auditing
• Perform and review shift GMP checks, environmental checks, and agent expiry dates, and ensure continued compliance
• 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
• Review and approve 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 Pharmacists and PMAs on SOPs in transition period
• 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
• Retrieve supporting documentation and records to facilitate and support query resolution

Requirements Background/experience

• BPharm Degree
• 1-3 years’ related work experience
• Pharmaceutical manufacturing experience 
• Specific job skills Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives Competencies
• Information gathering
• Interrogating information
• Meeting deadlines
• Finalising output
• Taking action Accountability & Decision Rights
• Work on assignments of moderate size, scope, diversity and/ or complexity
• Seek guidance when needed Decisions relating to:
• Own work methods, occasionally in ambiguous situations, guided by precedent, previous experience and known professional guidelines/ compliance requirements
• Interpretation of policies, standards, requirements and approaches

Closing Date: 22 February 2023

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Objective: 

• Responsible for the promotion of products within a certain geographical area to Hospitals, pharmacists, nurses and doctor specialists. Responsible for retaining and strengthening relationships with Key External Experts.

KEY RESPONSIBILITIES

Commercial Excellence

• Build positive trust relationships to influence targeted group in the decision-making process, and to increase sales
• Drive cross functional efficiencies and collaboration with key stakeholders across the business
• Responsible for guiding, detailing to pharmacists, nurses and specialist doctors within the hospital arena
• To support the retention and development of Key External expert relationships through the detailing of a therapeutic portfolio
• Understanding of research and development trends, building product awareness and aiding decisions surrounding product acceptance
• Influence the opinions and preferences of other healthcare practitioners, health authority representatives and patient advocacy groups towards trusted and preferred brands
• Follow up with targeted HCPs, gather feedback on their experience with Aspen/ Ethicare products and provide them with an ongoing customer support to ensure effective choice and use of the products
• Manage, coordinate, and administer portfolio within regional territory including planning, territory analysis, implementing customer targeting and call coverage of customer base
• Drive Focus brands
• Achieve and exceed set targets and market share objectives and track sales data to achieve or exceed sales budgets
• Provide ongoing customer support to create additional value in the business relationship including product training, external meetings, and webinars
• Resolve customer complaints by investigating problems; developing solutions; preparing reports; making recommendations to management
• Communicate and report on adverse reaction within 24 hours and ensure that all product complaints are resolved within the respective timelines
• Plan, organise and arrange training to Pharmacist/ Pharmacists assistants
• Implement area specific strategies that would positively impact the business and share best practices within the team
• Maintain adherence business rules i.e., call rates standards, call logging adherence and ensure submission of monthly and weekly planners and reports

Value creation

• Monitor and analyze data and market conditions to identify competitive advantage and product usage to improve sales performance
• Pursue continuous learning and professional development and stay up to date with the latest industry trends,
• Plan and organise and arrange training to HCPs
• Promote products ethically and within compliance based on company’s sales process and approved marketing strategy

Compliance

• Adherence to all CCCO expectations in customer interaction and activities

Requirements

 Skills and Attributes:

• Product knowledge on both Ethicare /Aspen and competitor products within hospital
• Effective territory management
• Knowledge of basic financial calculation i.e. Gross Margins, mark-ups.
• Analyzing of Aspen/ Ethicare in house data and external data sources
• Very strong communication and negotiation skills
• Administration skills
• Ability to work under pressure
• Excellent Presentation skills
• Problem solving and decision making
• Numerate, analytical, high attention to detail, able to prioritize
• Execution and understanding of set budgets

Knowledge:

• Knowledge of the Hospital business/industry
• Have a complete and thorough understanding of the scope of the pharmaceutical market
• Understanding of the budgeting and forecasting processes,
• A good grasp of marketing strategies and processes,
• Strong negotiation skills,
• Excellent communication and presentation skills
• MS office – with Advanced Excel Competency
• QlikView, TPM, IMS, SSD Models, Impact RX and Rep-wise Model

EDUCATION & EXPERIENCE

• Matric qualification.
• A tertiary medical/healthcare qualification.
• Minimum 5 years proven successful track record in pharmaceutical industry will be required, in hospital / specialist arena
• Minimum 5 years detailing experience to specialist doctors is essential.
• Existing relationships with key customers would be an advantage.
• Excellent interpersonal communication, presentation and negotiation skills
• Valid driver’s license
• Proficiency in Excel, PowerPoint, Outlook, Word, Qlikviejow, repwise  

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Description
Overview

• Provision of business support on all aspects of the area’s work
• Coordination and execution of administrative functions within the Solids Production areas
• Data analysis on shifts/ day performance for responsible areas including OEE, UPDT, SHE, quality, cost and absenteeism KPIs
• Update daily critical KPIs and reports to feedback to line manager

Requirements
Responsibilities

• Administrative support
• Provide input into work activities and priorities for the unit
• Organise and schedule meetings and monitor adherence to schedules
• Coordinate project and office services
• Perform advanced administrative, operational, customer support and computational tasks
• Prepare, compile and release documentation to external departments
• Update, edit and/or format SOPs when required
• Update production target board as required
• Perform shift stock take after each production shift
• Attend shift meetings
• Order/ buy stationery and consumables as and when required
• Perform any other administrative tasks related to work area as and when required
• Provide support in audits and pre-audits of batch record documents as per SOP Reporting and record-keeping
• Assist in the gathering information required for reporting
• Compile standardised reports and consolidate documents
• Maintain and update records and systems as required
• Retrieve supporting documentation and records to facilitate and support query resolution Stakeholder relations
• Communicate with internal stakeholders to achieve work objectives, maintain relationships and to assist and convey information

Requirements Background/experience

• Grade 12
• 1 to 3 years’ administrative experience Specific job skills
• Broad working knowledge of concepts, terminology and specialised admin requirements to support Production area Competencies
• Information gathering
• Articulating information
• Planning and organising

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Overview

• 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 and provide services according to Production plan.

Requirements
Responsibilities

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

• Overview Performs product recipe functions (BOM, routing, master data management, master batch record creation, validation and change management) in MES and ERP. Coordinates and supports administrative functions within Quality Systems Department

Requirements

Responsibilities :

Service Operations

• Request Fulfillment related to e.g. new recipe creation, updates to existing recipes within agreed SLAs.
• Incident and problem management related to MBR design.
• Co-ordination of technical resources to ensure adherence to agreed Service request SLAs.
• Application Management throughout entire system lifecycle.
• Service Design Design and coordination with key business stakeholders.
• Compliance of IT services, processes and systems with company policies and regulatory requirements.
• Alignment to architecture strategy, policies and standards.
• Ensure confidentiality, integrity and availability of data in line with regulatory requirements and company policies.

Service Transition

• Change Management, risk and impact evaluation.
• Manage and execute project activities, stakeholders and report on Deliverables, Risks, Assumptions, Issues and Decisions.
• Batch Record Validation and Testing – Compiling requirements, risk assessments, specifications and test protocols; testing and validation reporting.
• Service Release as per Service Introduction procedures. Asset and Configuration Management. Update Knowledge Base to improve efficiency

Service Strategy

• Understand and anticipate customer demand through demand management processes. Continuous Service Improvement
• Regularly review services to improve quality and identify areas where processes can be improved

Implement and monitor CSI initiatives Skills Required Background/experience

• Pharmaceutical (B Pharm) / Engineering / IT business degree or diploma.
• 1-3 years pharmaceutical manufacturing experience or Control & Automation, relevant IT development experience.
• Extensive experience working within a Pharma Quality Management System (QMS) with automated workflows. Specific job skills
• Good knowledge of local registrations and regulations and of international regulations/guidelines concerning GDP/GMP
• Advanced understanding of the pharmaceutical manufacturing processes. Pharmaceutical standards and compliance requirements.
• Excellent computer/ IT system skills and competencies
• Information Gathering and 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 optimize team performance.
• Resolve highly complex problems or out-of-policy issues. Independent decisions relating to:
• Technical risk based approach often in ambiguous situations, requiring advanced analytical skill, training / education.
• Establishing own work priorities and timelines.

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Background/experience

• 2-4 years’ Warehouse experience (preference in Pharmacare)
• Minimum of a National Certification (N4-N6)

Requirements

Requirements

Specific job skills

• Trainable to operate specialized MHE

Competencies

• Interrogating Information
• Meeting Deadlines
• Customer Awareness

Accountability & Decision Rights

• Prioritise and execute responsibilities for a single knowledge/ technical area or group of related tasks/ subject matter areas, with limited guidance and under general supervision
• Seek assistance on complex matters and ways to improve own work processes

Independent decisions relating to:

• Prioritisation and scheduling of daily work to complete tasks/ projects assigned by others
•  Reporting, correction and/ or containment of errors within established policies, practices and guidelines, and quality and safety checks
• Adaptation of methods to complete duties and responsibilities

Responsibilities

Receipting

• Check delivery vehicle and pallets for damage and ensure compliance to GMP
• Unpack the truck and sort by supplier and lot numbers
• Check shipping manifest and weigh materials; move suspect material to holding place
• Complete and verify the goods receipt document
• Hand receipt documents over to Administrator to book into BAAN
• Dust and pack by hand, and place on pallets, or by means of equipment
• Apply quarantine labels and/or location label on the material
• Hand over to the Administrator for printing

Stocking

• Place pallet on the shelf as per location label or scan location to update BAAN
• Replace the label after “For release” is approved, if applicable
• Place scheduled products into the Schedule Cages under supervision of Pharmacist

Picking

• Receive instruction to pick, locate and pick the pallet
• Place job number on the pallet and return completed picking instruction to Controller/ Administrator
• Secure the load
• Move it to the staging area for shipping

Quality Control

• Report any stock/or location variances
• Report issues to the superior
• Do general housekeeping
• Do general GMP and Health and Safety functions

Planning & procedures

• Prioritise daily work to complete tasks/ projects assigned by others
• Work within established policies, practices and guidelines, as well as established quality and safety checks

Asset/ Resource coordination

• Determine resource needs within own area of responsibility
• Request required assets and resources for the fulfilment of work duties