Responsibilities:
Ensure all manufacturing processes comply with local and international pharmaceutical regulations.
Conduct production line opening and line clearance checks as per SOPs.
Monitor adherence to Standard Operating Procedures (SOPs) and Good Documentation Practices (GDP).
Participate in regulatory audits and inspections, ensuring site readiness.
Review batch manufacturing records (BMRs) and packaging records to verify compliance.
Ensure correct SOPs, specifications, Bill of Materials (BOMs), and process parameters are followed.
Verify calibration status of measuring equipment used during production.
Check for proper traceability of raw materials, intermediates, and finished products.
Handle batch-related deviations and non-conformances, providing justifications where necessary.
Investigate non-conforming products, ensuring proper root cause analysis (RCA) is performed.
Implement corrective and preventive actions (CAPAs) for product defects.
Conduct trend analysis on defects and recommend improvements.
Investigate and respond to customer complaints, ensuring issues are addressed promptly.
Develop and update training materials and lesson plans for production staff.
Train operators and supervisors on GMP, SOP compliance, and quality standards.
Assess staff competency and ensure training records are maintained.
Conduct monthly GMP audits and report findings to management.
Update SOPs to reflect current production and quality assurance practices.
Participate in internal and external audits, ensuring audit findings are addressed.
Work on continuous improvement initiatives to enhance product quality and compliance.
Requirements
Bachelor of Pharmacy (B. Pharm) degree from a recognized institution.
Registered with the South African Pharmacy Council (SAPC) as a Qualified Pharmacist.
Additional GMP, ISO 9001, or PIC/S certification would be an advantage.
Strong knowledge of SAHPRA, GMP, PIC/S, and ISO 9001:2015 regulations.
Ability to work shifts, weekends, and extended hours when required.
Detail-oriented with strong analytical skills to evaluate production deviations.
Proficient in Microsoft Office (Word, Excel, PowerPoint) and electronic documentation systems.
Ability to work in a cleanroom environment and adhere to pharmaceutical hygiene protocols