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Aspen has a proud heritage dating back more than 160 years and is committed to sustaining life and promoting healthcare through increasing access to its high quality affordable medicines and products. Aspen has a market capitalisation of approximately US$10 billion, is the largest pharmaceutical company listed on the JSE Limited (share code: APN) and rank...
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- 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 and market share objectives.
- Effective implementation of sales and marketing strategies.
- Effective management of the regional territory by means of planning, territory analysis, customer targeting and call coverage of identified customer base.
- Establishment of positive relationships (mutual trust and respect) with customers and other stakeholders.
- Manage key customer sales and effective relationship management.
- Providing ongoing customer support.
- Add value to an entrepreneurial climate.
- Effective territory expense management and control.
- Active engagement with team members & piers in order to build an exciting and high-performance team and company culture.
Skills And Knowledge
- Product knowledge on both Aspen and competitor products.
- Effective territory management.
- Knowledge of basic financial calculation i.e. Gross Margins, mark-ups.
- Analyzing of Aspen in house data and external data sources.
- Strong ability to effectively communicate with both internal and external customers.
- Administration skills – ability to comply with the required administration standards associated with this position.
- Ability to work under pressure, to set priorities and to demonstrate time management skills.
- Creativity and flexibility – the ability to work in a changing environment and to adapt to different situations.
Education & Experience
- Matric qualification.
- Tertiary qualification would be advantageous.
- 1-2 years proven sales track record is essential.
- Previous basket experience/exposure would be an advantage.
- Valid driver’s license and own vehicle.
- Existing relationships with key customers in the territory would be advantageous
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Objective:
- Will be responsible for managing Key Accounts via driving and implementing Key Account Operational Plans aligned to the Strategic and Tactical Business Portfolio Plans. The successful incumbent will have customers across the FMCG segment such as Pharmacy Wholesalers and Pharmacy customers (not limited to) that include much growth potential. Drive achievement of sales budget for Consumer division, managing net revenue, operating income and trade expenditure. You will be required to collaborate and work cross-functionally and inter-departmental with Marketing, Sales, Finance, Supply Chain, Legal, Compliance and 3rd Party Logistics. Ensure the adherence to Aspen policies, systems and procedures.
KEY RESPONSIBILITIES
- Ensure all financial and non-financial objectives are achieved for Key Accounts as set by the Consumer Head in collaboration with the KAM Lead.
- Plan, implement, execute and monitors sales activities to drive performance on a national and regional territories.
- Be accountable and drive goals and objectives that are channel specific that include and not limited to Pharmacy, Retail and Pharma Wholesaler.
- Work closely with Finance and Debtors Team managing Operating Expenses and Debtors’ Management.
- Liaise with finance and legal department in coordinating and negotiation of trading agreements and expenditure tracking and management.
- Identify and develop new business opportunities in both sales channel and product portfolio.
- Ensuring all strategic negotiations become operationally visible through daily interaction and communication with sales, marketing teams and management.
- Prepare and manage budgets according to operational requirements and robust expenditure management.
- Monthly achievement & reporting on budgets
- Methods for improving customer services are proposed, developed and continuously updated.
- Ensure Aspen remains partner of choice in key product categories.
- Implement improvement in services and products via execution of channel-specific tactics.
- Ensuring adherence to legislations, the Self-Care Association marketing Code and Aspen’s values, policies and procedures
Requirements
Skills and Attributes:
- Planning skills
- Time management
- Problem solving
- Budgeting
- Forecasting
- Analyzing trends
- Service orientation
- Decision making skills.
- Interpersonal skills
- Strong Customer Relationship Management
- Communication skills
- Self-Motivated
- Negotiation skills
- Leadership skills
Attributes
- Initiative
- Accuracy
- Confidentiality
- Customer focused.
- Interpersonal sensitivity
- Logical thinking
- Information seeking
- Enquiring mind
- Self-development orientation
- Cultural sensitivity
- Vision
- Integrity
- Planning and organizing
- Analytical
- Decision making
- Commercial astuteness
- Ability to handle pressure.
- Negotiation skills
- Entrepreneurial spirit
- Persuasive
- Ability to delegate
- Flexible and strategic thinker
Knowledge:
- Knowledge of FMCG landscape across various key account channels
- Knowledge of processes
- Policy and procedure
- Customer data analytics
- Finance knowledge
- System knowledge
- Product knowledge
- Industry knowledge
- Future trend analysis
- Strategic marketing
- Pharmaceutical Laws i.e., Pricing / Marketing
EDUCATION & EXPERIENCE
- Matric Certificate
- A degree/ diploma / courses in relevant commercial/ healthcare environment (Advantageous)
- Min 3-5 years Sales / Marketing / Key Accounts management experience.
- Experience in setting and strategizing of account budgets, strategies, and tactics incl. Forecasting.
- Experience in customer negotiations i.e., Trade / Contracts etc.
- Strategic Market understanding and knowledge – essential.
- Substantial expertise and proven Customer Relationship Management
- MS Excel proficiency on advanced level
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POSITION OVERVIEW
- ServiceNow Applications Service Domain Lead plays a lead role in the delivery of ServiceNow implementation projects and driving strategic transformational change of IT solution deployment, IT operations management and IT business management processes. The Domain Lead is responsible for the overall design of a large-scale enterprise digital transformation using best practice principles in ServiceNow, in addition to creating a technical platform. Responsible for the architecture and drive implementation/integration of the product. Responsible and knowledge for the overall architecture, design, implementation, validation, and integrity of the application is critical.
ROLE PURPOSE
- Strategic, Tactical and Operational role accountable for the design and communication of high-level structures to enable and guide the design and development of integrated solutions that meet current and future business needs. Not limited to technology components of the Application, the role is responsible for defining ServiceNow E2E processes of various modules in ServiceNow, solution architecture encompassing changes to services, process, organization, and operating models. The provision of comprehensive guidance on the development of, and modifications to ServiceNow modules, Application configuration, and workflow configuration ensuring consideration to the relevant architectures, strategies, policies, standards and practices (including security) and that existing and planned solution components remain compatible and validated.
RESPONSIBILITIES
- Leads the development of solution architectures in specific business, infrastructure, or functional areas on a portfolio of applications.
- Lead domain, architecture, and technical aspects of projects and operational activities for ServiceNow and a Portfolio of applications responsible for.
- Provide strategic recommendation around technical best practices and industry trends on ServiceNow for Life Science Industry.
- Ensures that appropriate tools and methods are available, understood and employed in architecture development.
- Engage with the Aspen Business Units to position ServiceNow as the digital transformation platform standard, integrated with their core applications.
- Establish and manage a technical governance.
- Understanding and having experience in driving process optimisation, efficiencies and productivity using automation
- Serves as an active contributor of leading practices, standards, and thought leadership related to the ServiceNow platform
- Within a change programme, leads the preparation of technical plans and, in liaison with business assurance and project staff, ensures that appropriate technical resources are made available.
- Provides advice on technical aspects of solution development and integration (including requests for changes, deviations from specifications, etc.) and ensures that relevant technical strategies, policies, standards, and practices (including security) are applied correctly.
- Defines systems development projects which support the organization’s objectives and plans.
- Takes full responsibility for business analysis within the application area of the organisation where the advice given, and decisions made will have a measurable impact on the profitability or effectiveness of the organisation.
- Leads the selection of appropriate business analysis methods, tools, techniques, selecting appropriately from plan-driven/predictive approaches or more adaptive (iterative and agile) approaches.
- Participate in the design authority meetings to review technical solutions and approve them in the ServiceNow landscape.
- Develop system documentation, including process flows, SOP’s, and design standards.
- Establishes the contribution that technology can make to business objectives, defining strategies, validating, and justifying business needs, conducting feasibility studies, producing high-level and detailed business models, preparing business cases, overseeing development and implementation of solutions, considering the implications of change on the organisation and all stakeholders.
- Guides senior management towards accepting change brought about through process and organisational change.
- Keep check of instance performance and purpose improvement to improve end-user experience
Requirements
EDUCATIONAL QUALIFICATIONS AND EXPERIENCE:
- B. Com / BSc Computer Science degree or equivalent work experience
- Current industry certification in architecture (i.e., TOGAF, GxP, ISO 9000)
- Business Process Management Methodology (i.e., BPM, SDLC, ITIL, DevOps, Agile, COBIT)
- ServiceNow – Certified System Administrator (CSA)
- ServiceNow – Certified Implementation Specialist
- ServiceNow Platform Architect
- 10+ years’ experience of managing relationships with internal business customers
- Knowledge of web-based systems architecture, service-based architecture, enterprise application architecture
- Experience and sound knowledge of Business processes, best practises in solution delivery, auditing and assurance practices and improvement practices•
- 10+ years’ experience managing customer relationships in an operational and global services and automation in a large complex/matrix global organisation
- 7 to 10+ years’ experience in ServiceNow from a plan, build and run perspective and QMS systems.
- Consultancy experience will be advantageous
- Strong analytical skills, communication, and presentation skills
- Ability to manage customer and stakeholder expectations
- Have the drive and determination to learn and continuously share your knowledge with others
WORK-SPECIFIC SKILLS & EXPOSURE:
- 10+ years’ experience leading and influencing customers and matching needs to solutions
- 8+ years’ experience in solution architecture development and management
SKILLS AND ATTRIBUTES:
- Innovation
- Visioning
- Strategic planning
- Global thinking
- Entrepreneurial thinking
- Teamwork, Initiative
- Results oriented
- Systems thinking
- Focused
- Problem-solving
- Good judgment
- Responsibility and accountability
- Cooperation
- Proactive
- Resilience
- Active listening G
- Presentation skills
- Meeting facilitation
- Organisational awareness
- Influence skills
- Good judgment and approach to delivering a solution that optimizes architecture activities across company needs, business constraints and technological realities.
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Overview
- Provision of business support on all aspects of the area’s work
- Coordination and execution of administrative functions within the Quality area
Responsibilities
Administrative support
- Provide input into work activities and priorities for the unit
- Monitor adherence to schedules, organise and schedule meetings, monitor quality area activities, and plan and make travel arrangements
- Prepare, compile and release documentation to external departments
- Coordinate project and office services
- Performs advanced administrative, operational, customer support and computational tasks
Process compliance (CAPAs, change, controls, deviations)
- Administer CAPAs requests
- Coordinate the required tracking of change requests to SOPs and processes, and assist in determining compliance with control process
- Assist in analysing deviation trends
- Coordinate the required tracking of overdue CAPAs, CCs, deviations and internal audit reports and responses
External audits management
- Coordinate audits relating to document and information management
- Coordinate and provide support during external and customer and statutory external audits
Management review, reporting and record-keeping
- Assist in tracking and reporting on in-country quality metrics
- Assist in the gathering and consolidating/ compiling information required for reporting
- Consolidate documents
- Maintain and update records and systems as required
- Retrieve documentation and records to facilitate query resolution
Stakeholder relations
- Communicate with internal stakeholders to achieve work objectives, maintain relationships and to assist and convey information
- Schedule meetings with local suppliers
Requirements
- Background/experience
- 3 to 6 years of relevant experience
- Grade 12 Certificate
Specific job skills
- Broad working knowledge of concepts, terminology and specialised admin requirements to support Quality area
Competencies
- Information Gathering
- Following Procedures
- Planning and Organising
- Meeting Deadlines
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Description
Overview
- Monitor, maintain and repair equipment and machinery adhering to GMP and safety requirements
- Plan and implement preventative and corrective maintenance
- Ensure service equipment operates at optimal efficiency to meet planned levels of production
- Innovate and apply process engineering techniques to ensure optimal functionality of production equipment and processes
Requirements
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
- Train staff on SOPs and maintenance of equipment/ machinery Production Facility Maintenance
- Plan technical requirements and maintenance tasks according to production requirements to meet Production Plan
- Review and update maintenance schedules
- Perform planned preventative maintenance and inspections according to maintenance plan, job cards, and SOPs
- Repair breakdowns according to best practice, job cards and SOPs
- Troubleshoot machine breakdowns to identify cause of breakdowns
- Perform root cause analysis to identify cause of machine failures and quality deficiencies to minimise machine downtime
- Implement corrective actions to minimise machine downtime
- Isolate, remove and replace defective components
- Complete and submit work requisitions; Create and close job cards
- Maintain workshop, tools and assets to standards
- Determine and request required parts, materials and special equipment to maintain machines/ equipment
- Install, test and validate machine operating efficiency Mechanical Engineering
- Maintain calibration of machines according to SOPs and manuals, ensure machine safe guards are in place
- Identify and correct equipment deviations to avoid quality deficiencies; Reduce outsourced spending of repairs
- Inspect service equipment and report status to Team Leader ▪ Rectify operational problems according to SOP
- Communicate process and equipment deviations to management
- Provide input into asset life cycle optimisation and replacement
- Assist production staff with change-overs Reporting and record-keeping
- Provide standard record keeping and reporting functionality for area of Requirements
Background/experience
- Trade Tested Mechanical Artisan (Fitter/Fitter or Turner/Millwright) with 2 to 4 years’ post Apprenticeship experience as a trade tested artisan
- Pharmaceutical Technician Certificate will be an advantage
- Manufacturing experience
- Experience in operation and maintenance of Pharmaceutical manufacturing/ packaging systems Specific job skills
- Comprehensive knowledge of pharmaceutical manufacturing, standards and compliance requirements
- Understanding of technical drawings / use of equipment manuals
- Ability to interpret and implement policies, processes and objectives
- Physically capable of lifting/ moving heavy equipment Competencies
- Interrogating Information
- Pragmatic Action
- Maintaining Accuracy Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.
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Description
Overview
- Review and approve batch documentation in line with SOP and quality standards
- Perform lab quality review in line with SOP
- Provide services according to Production plan
- Related administrative tasks
Requirements
Responsibilities
Planning and Operational Support
- Oversees work and/ or serve as a lead technical expert
- Optimise and facilitate implementation of current processes
- Identify gaps in current policies and procedures
- Propose changes or improvements to processes, tools and techniques
- Provide information for reports, as required by superior
- Provide analytical support in the absence of the TL
- Provide support during regulatory audits
Lab Quality Review
- Perform LQRs according to Production plan
- Review and approve lab records to ensure pharmaceutical analysis has been carried out as per MOA; direct queries to laboratory
- Electronic approval of analytical results on relevant software. e.g. Empower
- Evaluate and interpret chromatography data to ensure accuracy of results.
- Review and approve batch documentation compliance with SOPs and quality standards
- Correct errors in batch documentation, in line with GMP standards, SOPs, and product specifications
- Record all OOS investigations and conclusions, and report to management
- Provide advise to analysts during laboratory investigations.
- Provide input into SOPs
- Ensure that products are produced, tested and stored according to the required SOP’s and documentation
- Ensure adherence by Analyst/ Tester before release
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
- Compile detailed and standardised reports and consolidated documents
- Initiate deviations once picked up during reviewing
Skills required
Background/experience
- National Diploma in Analytical Chemistry with 6+ years experience
- Laboratory experience
Specific job skills
Competencies
- Interrogating Information
- Following Procedures
- Maintaining Accuracy
- Customer Awareness
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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.
- Comms to be done, or as specified by the business. Final Comms to be done after the last call for each day
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
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
Requirements
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
- Ensures effective implementation and management of accounting controls within Production departments. Prepares accurate and timely financial reports on Production activities.
Responsibilities :
Budgets and Reporting
- Assist in preparing the expense budget
- Prepare performance reports
- Set annual budgets and quarterly forecasts
- Prepare rework quotations, as required
Financial Controls
- Control inventory in area of responsibility
- Meet output requirements, while containing expenditure
- Assist with stock counts
- Analyse variances, including usage/ yield variances, inventory write-offs, recoveries, expense analysis, headcount analysis in terms of budget vs. actual, trends and feasibility, etc.
- Review, analyse and report on cyclical/ stock count results
- Review stock processes
- Prepare forecasting of recoveries and expenses, in consultation with Manager and operations leader
- Identify, report and provide feedback on risks present in the operation
- Meet targets on yields and write-offs
- Ensure control and approval of expenses in accordance with the company approvals framework
- Ensure annual stock takes meet control requirements
Operational Input
- Provide technical and operational input on operational planning of the unit and on the prioritisation of objectives
- Indicate required changes in resources to enable achievement of work objectives
- Monitor and control use of resources in area of responsibility
- Apply advanced understanding of area of specialisation
- Analyse concepts and suggest streamlined procedures
- Provide information for reports, as required by Supervisor
- Compile standardised reports and consolidate documents
- Comply with document filing requirements and maintain and update records and systems as required
- Assist with development/amendment of SOP's
- Assist with projects, implementation of systems and feasibility studies
Requirements
Background/experience
- 4 to 6 years’ accounting experience in a manufacturing organisation
- Experience advising management on finance-related matters and implementing financial controls
- BCom Degree in Financial Field
Specific job skills
- Computer literacy: proficiency in Excel, Word, Powerpoint, and a fully integrated ERP system
Competencies
- Offering Insights
- Maintaining Accuracy
- Managing Performance
- Interrogating Information
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Overview
Coordinate QS activities, including:
- Quality Risk Management (QRM), root cause analysis, change control and product failures
- Recording and trending of data
- Documentation systems and controls
- Interpret and implement quality procedures, standards and specifications
- Coordination and management of APQR, PQR and customer complaints
- Coordination and management of regulatory audits
Responsibilities
Planning and section management
- Provide technical and operational input on operational planning of the unit and on the prioritisation of objectives
- Provide input into budget and resource requirements of section
- Request, allocate and monitor use of assets and resources
- Provide section staff with day-to-day direction and tasks
- Run effective performance review meetings
- Ensure visual performance boards are updated
- Complete and monitor time and attendance
Policy, procedure and document management
- Provide input into and implement quality manuals and policies
- Draft and maintain SOPs and process docs; review output documents
- Maintain compliance with recordkeeping regulations
- Implement QRM and continual improvement systems/ programmes
- Participate in investigations into process and quality problems and preventative planning
QS implementation
- Coordinate APQR and PQR processes
- Oversee generation, investigation, documentation, implementation, verification, closure, effectiveness and trending of CAPAs
- Coordinate and monitor complaints handling and investigations processes, including complaint intake, triage and investigation, handling of returns and recalls, and interacting with health authorities
Process compliance
- Manage the implementation of changes to SOPs and processes
- Monitor implementation and correct compliance with legislation, policies and procedures
- Oversee QS involvement in external (regulatory) audits
Review and reporting
- Manage and oversee data integrity activities
- Coordinate data collection, trending and analysis of KPI’s and tracking and reporting on quality metrics
- Prepare draft reports
Requirements
Job Requirements
- Background/experience
- Minimum of Bachelor’s degree (B Pharm)
- Minimum 4-6 years’ related work experience
- Pharmaceutical manufacturing experience
Specific job skills
- Strong working knowledge of pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- People management
- Ability to interpret and implement policies, processes and objectives
Competencies
- Interrogating Information
- Managing Performance
- Offering Insights
- Taking Action
- Setting Standards
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Overview
- Support the Master Production Scheduler with the development, planning and execution of the master production schedule. Assist with adjusting backlogs. Provide production with manufacturing plans, aligned with master production schedule, acting as production facility liaison.
Responsibilities
Operations scheduling
- Support in short-term planning in daily buckets, rolling 3 to 4 weeks, ensuring smooth work centre loading, accurate dates and production feasibility
- Monitor production carry-overs and report on risks
- Assist Master Production Scheduler with adjusting for backlogs; reschedule to reflect realistic delivery dates
- Advise the Master Production Scheduler of scheduling conflicts
- Print and release production orders according to plan
- Ensure material availability
- Prioritise Lab testing, release of raw materials and packaging component
- Perform root cause analysis for late production orders
Procurement liaison
- Communicate material shortages with Buyers
- Confirm delivery dates with Buyers and expedites purchase orders
- Discuss material shortages, quality and specification issues with Buyers
Production liaison
- Meet with production department to discuss plan and ensure production execution to plan
- Attend meetings as required with Lab and Production to support multi – functional teams
- Amend production order delivery dates to reflect realistic delivery dates
Requirements
Background/experience
- 2year Diploma in Logistics or a related field
- At least 4 years’ relevant experience
- Experience in a production planning environment
Specific job skills
- Computer literacy, including proficiency in the use of MS Excel and MS Word
Competencies
- Information Gathering
- Taking Action
- Planning and Organising
- Capturing Facts
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Overview
- Facilitate and supervise validation exercises. Provide technical support, process control and process improvement activities to support validation activities. Assist with validation activities. Performance management of direct reports.
Responsibilities:
Planning and Section Management
- Execute and implement policies and procedures
- Provide input into budget and resource requirements for section
- Provide staff with day-to-day direction and tasks
- Support Validation Officers through training, facilitating and problem solving activities
Validation
- Develop, implement and review validation plans, SOPs and protocols to ensure continued compliance at all times
- Coordinate validation activities with QC and Production
- Oversee the completion of validation activities according to validation plans/ schedule
- Evaluate risk from executed validation protocols
- Investigate deviations from validation protocols, identify root causes, and develop and implement CAPA plans
- Assist with review of re-validation plans
- Maintain and audit compliance of validation activities
- Ensure test equipment is maintained and calibrated as per approved schedule, and documented
Qualification
- Coordinate qualification activities with QC and Production
- Compile, implement and perform the relevant qualification protocols as per SOP
- Participate in change control assessments to ensure compliant status of affected equipment is not compromised
- 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
Governance, Risk and Compliance
- Review accuracy and integrity of protocols, reports and documentation generated comply with regulation
- Review compliance of validation documentation with QMS
- Generate validation reports on a weekly/ monthly basis
- Monitor implementation and correct own and/or team compliance with legislation, policies and procedures
Participate in internal and external audits
Requirements
Background/experience
- Certification/ Diploma and a minimum of 5 years of related experience
- Supervisory/ Management experience
- Experience in validation techniques and computer related systems qualification
- Experience in validation of secondary processes associated with filling lines and isolators such as vaporized hydrogen peroxide (VHP), clean in place (CIP), steam sterilization in place (SIP) and aseptic process simulations will be advantageous
Specific job skills
- Comprehensive knowledge in the application of Qualification and Validation principles
- Knowledge of control and instrumentation systems, electrical systems and reading of electrical diagrams
- Understanding of pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
Competencies
- Interpreting and internalising information
- Planning and organising
- Meeting deadlines
- Taking action
- Working in teams
Method of Application
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