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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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Overview
- Manage and support production support activities
- Responsible for the process and component development and equipment acquisition for new product manufacturing
- Provide investigation and institute corrective action functions
Responsibilities
Component Investigations in Production
- Conduct level 2 investigations related to component issues in production
- Collaborate with the supplier packaging specialist to ensure resolution of component issues, and improve component interaction with manufacturing equipment
- Drive process improvement and output improvement by assessing the optimizing equipment/ component interaction
- Suspect Block Form (SBF) Process
- Conduct suspect stock investigations
- Decide whether to reject packaging stock
- Complete the relevant forms and inform internal personnel and external suppliers
Internal Customer Complaints
- Receive, address, resolve and respond to complaints/ concerns related to packaging
- Escalate the complaints if unable to resolve
Packaging Engineering
- Conduct packaging trials
- Conduct tooling design; indicate the manufacturing components and machines needed for production
- Track and trace the passage of prescription drugs through the entire supply chain (Serialisation)
Asset/ Resource Coordination
- Provide input into required changes in own resources
- Request and allocate required assets and resources for the fulfilment of work objectives
- Monitor the use of assets and resources within own area of responsibility
Technical Expertise
- Propose changes or improvements to management on processes, tools, techniques, and products
- Provide expert advice for issues experienced by internal stakeholders
Requirements
Background/experience
- 6 or more years’ experience in the pharmaceutical industry
- Minimum of a National Diploma in Electrical/ Mechanical Engineering or similar
Specific job skills
- Project control and development
Competencies
- Innovative Thinking
- Making Decisions
- Meeting Deadlines
- Working in Teams
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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
Skills required
Background/experience
- Certification/ Diploma and a minimum of 5 years of related experience
- Hold a degree or equivalent qualification in Science (Chemistry, Microbiology) or Engineering (Chemical, Pharmaceutical or Process), or equivalent industry 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 Vaporised Hydrogen Peroxide (VHP), Clean in Place (CIP), Steam Sterilisation in Place (SIP), Aseptic Process Simulations and Process Performance Qualification (PPQ)
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
- 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
- Technical writing skills
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Overview
- Conduct in-process compliance to quality procedures, standards and specifications for value stream operations
- Review and approve Annual Performance Quality Review (APQR) and quality related activities
- Ensure in-process materials and finished products comply with GMP guidelines, regulation, and in-house SOPs
- Ensure product release for use into the marketplace ensuring compliance with local regulations, Aspen Ops guidelines and other marketing authorization requirements and guidelines
- Control of documentation in compliance with regulation and company policies and procedures
- Ensure all relevant GMP and GDP processes are described in the current SOPs and re-adhered to correctly
- Perform quality risk assessments, establish risk controls and review risks to assist with the quality risk management process
Responsibilities
Planning & Processes
- Provide technical and operational input during drafting of plans and procedures specific to unit
- Implement and coordinate systems and procedures and make decisions within policies and procedures, or as authorised by superiors
Product Release
- Review batch documentation and production conditions to assess compliance to quality procedures, standards, and product specifications
- Review and approve quality of new, in-process and released batches to assess compliance to quality control programs, product specifications, and GMP guidelines
- Approve and release production batches
- Execute batch release priorities in line with OTIF and planning schedule
- Ensure release requirements are met for finished products
- Determine disposition of in-process and finished products for clinical and commercial use
- Ensure changes / deviations in production or quality control have been approved according to QMS
- Initiate tests / checks / inspections / sampling to mitigate and risk associated with planned changes / deviations
- Ensure production and QC documentation are completed an in compliance with SOPs
- Monitor and audit compliance to regulatory and in-house standards with regards to current GMP
- Report observed deficiencies in process and follow up on corrective action
- Investigate systematic quality problems and develop preventative plans, in conjunction with Production
Process Compliance
- Identify systematic technical and process issues by reviewing CAPA requests and trends
- Systematic investigation of the root cause of identified problems and risks for corrective action or prevention
- Develop CAPA plans and change incidents to address process compliance
- Implement operational changes to SOPs and processes, in compliance with control processes
- Ensure deviations (planned / unplanned) are documented, reviewed, and analysed and recommend validation activities to be performed
- Execute change control process by ensuring changes are documented, reviewed and approved
Annual Performance Quality Review
- Review APQRs to assess production risks and quality of in-process control programs
- Review and analyse CAPA plans to assess impact on quality procedures and standards
Retention Sample Management
- Store and manage retention samples as per guidelines
In Process Quality Management
- Review and approve outcome of in-process internal inspections
Reporting
- Ensure the filing, retrieving and archiving of documents on the soft and hard copy filing systems
- Maintain and update records and systems as required
- Provide information for reports on weekly / monthly basis, as required by superiors
- Compile and complete standardised reports and consolidate standardised documents
Requirements
Skills required
Background/experience
- BPharm Degree with 2 years’ pharmaceutical manufacturing experience
- South African Pharmacy Council registration
- 1-year related work experience
Specific job skills
- 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
- Finalising Outputs
- Offering Insights
- Meets Deadlines
- Taking Action
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Overview
- Develop, manage and monitor quality procedures, standards and specifications for value streams in compliance with regulations
- Manage and monitor core QA activities for value streams
- Review and approve in-process QA programs and activities
- Manage and guide the unit through team leaders
- Performance management of direct reports and unit
Responsibilities
Planning & Processes
- Interpret, implement, and coordinate systems, processes, policies and procedures contributing to the quality assurance in the unit
- Provide input into existing systems, procedures and policies that impact in-process control activities in value stream operations and quality in the unit
- Attend L2-3 meetings
Financial & Resource management
- Provide input into the functional financial plan/ budget based on operational requirements
- Ensure availability and optimal allocation of resources within unit
People Management & Development
- Implement human resource policies
- Participate in training, coaching and development for team members
- Develop and implement performance contracts and succession plans
- Manage conflict, disciplinary and safety issues
- Assist with recruitment
Product Release
- Lot release and/or rejection of starting materials, packaging materials, intermediate, bulk and finished products.
- Review and approve process to release disposition of products
- Determine batch release priorities in line with On Time In Full (OTIF) and planning schedule requirements
- Perform batch release when required
- Process Compliance
- Review and approve CAPA plans to address systematic issues
- Review and approve operational changes to SOPs and processes
In Process Quality Management
- Review and approve process for in-process quality management
- Ensure effective Review and Monitoring of Supplier management system
Governance, Risk & Compliance
- Participation in Management reviews and escalation of quality issues
- Ensure unit’s activities comply with operating guidelines and policies for the organisation and function.
- Monitor and correct compliance with legislation, policies and procedures to impact on the effectiveness of QMS
- Review and approve Document Retention procedures
Requirements
Skills Required
Background/experience
- Minimum of Bachelor’s degree (BPharm) preferred
- 7 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
- Offering Insights
- Managing Performance
- Planning and Organising
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Responsibilities
Talent Acquisition
- Secure accurate profiles, grades and level of vacancy informing the recruitment process
- Conduct external and internal recruitment for all Grade DL vacancies at SA Operations, in line with policy and legislation, within a turnaround time of 30 days
- Determine, in line with line management, the assessments required related to a job, document decisions and implement during recruitment process
- Coordinate relocation assistance where required and take responsibility for inclusion in employment contract
- Work with line management to ensure a smooth, timely and cost-effective recruitment and selection process
- Maintain up to date knowledge on best practice recruitment and selection techniques with specific attention to E, D & I
- Maintain good communication with all relevant stakeholders to foster a positive Employer Brand experience
- Develop talent pipeline at SA Operations to ensure business continuity and transfer of skills
- Track and report on Talent Acquisition metrics to measure and evaluate effectiveness of programmes, processes to ensure continuous improvement
- Build and coordinate an onboarding and offboarding programme that fosters a positive employee experience
Talent Management
- Implement and monitor Succession, Career Pathing and Retention strategies in line with Talent Management Policy Framework and Governance
- Educate Line Managers on Succession, Career pathing and Retention policies and processes and develop toolkits for implementation
- Develop metrics to understand where talent sits and where critical skills gaps are at SA Operations
- Identify mission critical and key person roles to determine need of successors, and identify current incumbents in key positions
- Identify high potential candidates for the succession planning programme, based on experience and competencies
- Assess skills and experiences required for unmatched critical positions, and report output to line managers
- Consolidate exit interviews and report on trends
- Report to line mangers the risk areas, where no match exists between potential succession candidates and required skills and experience
- Review and monitor periodically the progress of SA Operations succession planning program, and highlight program adjustment, where and when needed
- Identify and propose criteria for identifying candidates as long term and short-term replacements
- Track and report on Talent Management metrics to measure and evaluate effectiveness of programmes, processes to ensure continuous improvement
- Coordinate Talent Review forums for SA Operations
Performance Management
- Implement the Group Performance Management Framework and toolkits to guide employee effectiveness
- Advise and assist HC Business Partners on how to guide line managers to set SMART objectives for their direct reports and teams
- Provide training to Human Capital Business Partners on Performance Management
- Provide bi-annual and annual data on Performance Management to ensure accurate and reliable management information that facilitates executive decision making
- Coordinate the annual Performance Review process
- Ensure the Performance Improvement Programme is implemented fairly across SA Operations
- Track and monitor PIP implementation in collaboration with Business Partners
- Track and monitor performance of successors and suggest strategies to close development gaps
- Stay abreast of changing strategies, conduct research and make recommendations on new designs, systems, approaches and applications in the area of Performance Management
Employment Equity
- Support the implementation of the Employment Equity plan and own EE monitoring and reporting at site level
- Drive compliance to Employment Equity targets according to EE plan
- Facilitate training and development on employment equity plans and provide guidance on how to meet targets
- Consult with relevant stakeholders on employment equity matters
- Support the development and implementation of transformation action plans
- Contribute to the Employment equity meetings as a trusted partner, advisor and champion of Transformation
- Help develop and coordinate SA Operations EE reporting and monitoring tools
- Ensure the internal processes are aligned with the employment equity legislations
- Coordinate the execution of transformation strategy and communication for all related projects
- Drive EE activities such as road shows, training and communication to create awareness of EE issues
- Drive the internal set up of affirmative action goals
- Ensure the EE file is updated and audit-ready at all times
Equity, Diversity and Inclusion
- Champion Equity, Diversity and Inclusion initiatives at SA Operations
- Lead and implement transformation initiatives to create a diverse workforce
- Initiate and drive comprehensive employment equity/affirmative action strategies to ensure the business drives the equity initiatives in a systematic way (gender/racial/localization/disability)
- Guide and support the SA Operations business to drive transformation in their business units
- Provide input into the design and development of policies and procedures to enhance Equity, Diversity and Inclusion within the business
Requirements
Skills Required
Background/experience
- Degree in Huma Resource Management or equivalent field
- 3 – 5 years’ experience in areas of talent management, talent acquisition, succession planning, performance management, Employment Equity and EDI (Equity, Diversity and Inclusion)
- Certification in Learning and Development would be a distinct advantage
Specific job skills
- Experience within the Talent Management and Learning & Development functions is essential
- Generalist HR experience would be an advantage
- Experience in Succession Planning would be an advantage
- In-depth and applied knowledge of talent management models, succession planning, employment equity act, diversity and inclusion programme development and retention strategies
- Knowledge and ability to apply various candidate assessment and selection methodologies, tools and platforms and ability to effectively align them with specific recruitment needs
Competencies
- Performance Driven
- Accountability / Ownership
- Communicate Effectively
- Deals with ambiguity / embraces change
- Continuously grows and develops
- Contributes special expertise
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Overview
- Perform microbiological tests on raw materials, water, cleaning and environmental samples, in-process and final products to ensure quality and compliance
- Review compliance of documentation according to pharmaceutical standards
Responsibilities
Planning and Operational Support
- Optimise and facilitate implementation of current processes
- Identify gaps in current policies and procedures
- Propose changes or improvements to processes, tools and technique
Microbiologist Testing
- Perform microbiological tests on raw materials, in-process and final products to ensure quality and compliance with GMP standards
- Test water according to SOPs and testing schedule
- Notify Production of source of any contamination timeously
- Develop and implement plans to control level and source of contamination
Environmental Management
- Perform sampling and testing of external environment, according to SOPs and sampling plan/ schedule
Quality Control
- Report OOS results and deviations immediately
- Manage frequency of testing and sampling to maintain a quality process
- Maintain good housekeeping
- Manage and coordinate the use, maintenance and calibration of testing equipment according to SOPs
- Ensure continuous compliance of laboratory with GMP standards
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
Skills Required
Background/experience
- National Diploma in Microbiology
- Microbiological laboratory with 6+ years experience
Specific job skills
- Advanced knowledge of microbiological testing methods
- Understanding of pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
Competencies
- Interrogating Information
- Following Procedures
- Maintaining Accuracy
- Customer Awareness
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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
- Provide services according to Production plan
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
- 2+ years 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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Overview
- Perform sampling, labelling and inspection of material
- Perform routine testing
- Maintain good housekeeping
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
Test Preparation
- Handle materials in sampling areas according to SOPs
- Maintain good housekeeping in sampling areas
- Prepare reagents and solutions when required
- Prepare lab according to SOPs
- Prepare and maintain equipment, PPE and facilities
- Sample materials for testing according to SOPs and sampling plans
- Analyse samples to ensure compliance with specification
- Report any non-conformances/ compromised samples
- Document released test samples for customer consumption
- Label and release sampling material according to SOPs
QC Lab Testing
- Perform routine testing on equipment according to SOPs
Stability Testing
- Perform routine stability tests according to SOP
Water Testing
- Perform daily and weekly water testing according to SOP
Packaging Testing
- Perform routine package testing according to SOPs
- Examine labelling/ artwork and identify mislabelling/ breaches; report discrepancies
Reporting and Record-Keeping
- Document and file data according to SOPs and regulation
- Update records and systems as required
- Record and report results; OOSs to be reported to supervisor
Requirements
Skills Required
Background/experience
- Grade 12 with Mathematics and preferably Physical Science or Biological Sciences
- 1-3 years laboratory experience
Specific job skills
- Comprehensive understanding of pharmaceutical testing methods, laboratory processes and procedures
- Good Laboratory Practice
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
Competencies
- Information Gathering
- Interrogating Information
- Maintaining Accuracy
- Following Procedures
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Overview
- Set up, open and change over the production line for processing
- Monitor production performance to ensure optimal performance and conformance to standards and specifications
- Perform first line maintenance on production equipment
- Problem solving and troubleshooting
- Provide on the floor system expertise
- Ensure data integrity compliance to BMR for on time batch release
Responsibilities
Planning and Operational Support
- Oversee work or serves as a lead technical expert
- Optimise and facilitate implementation of current processes
- Identify gaps in current policies and procedures
- Propose changes/improvements to processes, tools and techniques
Production Preparation
- Perform strip down, set up, adjustment, start up of production line
- Perform Type A and Type B changeovers according to SOPs
- Assist Validation on new projects (run speeds, equipment, etc.)
- Order change parts, tools and spares to meet production plan
Production Processing
- Attend to mechanical and electrical breakdowns/ repairs as needed
- Monitor line performance and make electrical/ mechanical adjustments where needed
- Perform planned preventive maintenance as per plan/ schedule
- Verify measuring equipment according to SOP and standards
Routine Support Tasks
- Perform equipment pre checks according to SOP
- Assist with campaign preparation
- Perform equipment transfers according to SOPs and standards
- Train new Technical Manufacturers
Troubleshooting
- Perform root cause analysis to identify root cause of failures
- Perform equipment adjustments to limit downtime; escalate major breakdowns to Engineering
- Raise downtime notification with Production Leader
- Isolate and lock out machines to be set/maintained per SOP
- Assist Engineering in the correction of equipment problems
Process and System Improvements
- Perform product and method improvement investigations
- Identify and execute improvement opportunities to reduce overall downtime and increase operational performance
Admin and Record keeping
- Perform half hourly inspections
- Attend shift meetings
- Complete OEE reports
- Consolidate and analyse information; compile detailed reports
- Monitor and control access to and set-up of electronic databases
Requirements
Skills required
Background/experience
- Trade Tested Artisan with 2 to 4 years’ post Apprenticeship experience or National Diploma with 1 to 3 years’ related experience
- Experience in production processes and operation or first line maintenance of production equipment
Specific job skills
- Advanced knowledge and understanding of setting up and running high speed PLC operated production equipment, process flow and associated critical control parameters
- Advanced understanding of pharmaceutical manufacturing, standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
Competencies
- Finalising outputs
- Following procedures
- Taking action
- Information gathering
Method of Application
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