Job Purpose
- To provide pharmaceutical and technical oversight of manufacturing operations, ensuring that all products are manufactured, packaged and documented in accordance with approved procedures, Good Manufacturing Practice (GMP), SAHPRA requirements, company quality standards and approved product specifications.
- The incumbent is responsible for ensuring compliance within the production environment, maintaining production documentation, driving continuous improvement initiatives and supporting the development, review and implementation of Standard Operating Procedures (SOPs) to ensure the consistent manufacture of safe, effective and high-quality pharmaceutical products.
GMP Compliance, Production Oversight & Quality
- Ensure all manufacturing activities are performed in accordance with:
- Current Good Manufacturing Practice (cGMP)
- SAHPRA requirements
- Approved SOPs
- Master Batch Manufacturing Records
- Registered product specifications
- Ensure manufacturing processes are consistently executed and documented accurately.
- Monitor production operations to ensure compliance with quality, safety and regulatory requirements.
- Ensure manufacturing areas are maintained in a state of inspection readiness at all times.
- Verify that line clearance activities are completed and documented before commencement of production activities.
- Ensure appropriate segregation, identification and status labelling of materials and products.
- Foster and ensure maintenance of and compliance to high-quality standards and regulatory requirements.
- Promptly take action and report to the immediate Supervisor any out-of-specification results
- Ensure that no packaging and manufacturing activities are performed under non-compliant environmental conditions.
- Ensure that the daily verification of ALL the scales/balances in the area has been performed and the necessary documentation completed and checked before commencing with packaging and manufacturing activities
- Ensure that out-of-calibration scales are labelled clearly as such, removed from the area where possible and that they are not used in the area
Batch Documentation & Record Review
- Review completed batch manufacturing records for accuracy, completeness and GMP compliance.
- Ensure all production records are completed contemporaneously and in accordance with data integrity requirements.
- Verify reconciliation of materials, yields and packaging components.
- Ensure production documentation is retained, controlled and archived according to company procedures
SOP Development & Document Management
- Draft, review, revise and update Standard Operating Procedures (SOPs), work instructions, batch manufacturing records and other GMP documentation.
- Ensure all production-related procedures remain current, effective and compliant with regulatory requirements.
- Participate in periodic reviews of SOPs and manufacturing instructions.
- Ensure controlled implementation and communication of revised procedures.
- Provide technical input into the development of new procedures and process improvements.
Key Job Outputs
Deviations, Investigations & CAPA
- Investigate production deviations, non-conformances and quality incidents.
- Conduct root cause analysis and implement effective corrective and preventive actions (CAPAs).
- Support investigations relating to:
- Out-of-Specification (OOS) results
- Out-of-Trend (OOT) results
- Customer complaints
- Product quality concerns
- Monitor effectiveness of implemented CAPAs
Validation & Continuous Improvement
- Support process validation, cleaning validation and equipment qualification activities.
- Participate in risk assessments and change control processes.
- Identify opportunities to improve manufacturing efficiency whilst maintaining product quality and compliance.
- Facilitate implementation of continuous improvement initiatives within production.
Training & Competency Management
- Ensure all production personnel are trained and competent on:
- GMP requirements
- SOPs
- Manufacturing processes
- Data integrity requirements
- Health and safety procedures
- Conduct SOP and GMP training as required.
- Maintain accurate training records and ensure training compliance.
Audit & Regulatory Support
- Participate in internal, customer and regulatory audits.
- Support responses to audit findings and implementation of corrective actions.
- Ensure production areas remain audit-ready and compliant with GMP requirements.
- Assist during SAHPRA, customer and third-party inspections.
Health, Safety & Environmental Compliance
- Ensure compliance with Occupational Health and Safety requirements.
- Promote a culture of safety, quality and compliance.
- Report and investigate safety incidents within the production environment.
Adhoc
- Perform any other duties as may reasonably be required from time to time, in line with the scope of the role, organisational requirements and the incumbent’s skills, qualifications and level of responsibility.
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