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 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
- Interrogating Information
- 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
