Inspector: Good Manufacturing Practice (GMP) at South African Health Products Regulatory Authority

REQUIREMENTS:

• Matric certificate and appropriate four-year Bachelor of Pharmacy degree and registration as a Pharmacist with the South African Pharmacy Council (SAPC) at NQF level 8 as recognised by SAQA. A relevant Master’s qualification at NQF level 9 as recognised by SAQA will be an added advantage. Valid driver’s licence. 

EXPERIENCE:

• Grade 1: Four-year Bachelor of Pharmacy degree NQF or Honours degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA plus a minimum of five (5) of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience in undertaking GMP inspections within a regulatory environment.
• Grade 2: Four-year Bachelor of Pharmacy degree NQF level 8 as recognised by SAQA and registration as a Pharmacist with South African Pharmacy Council (SAPC) and a minimum of three (3) years of experience in a pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience in undertaking GMP inspections within a regulatory environment or an Honours degree in Chemistry or equivalent related qualification at NQF level 8 as recognised by SAQA, plus a minimum of ten (10) years of experience in pharmaceutical regulatory or GMP environment. Extensive knowledge of GMP regulations and industry practice, as well as substantial experience in undertaking GMP inspections within a regulatory environment.

DUTIES:

• Inspect pharmaceutical manufacturing sites for compliance with Good Manufacturing Practices as accepted by SAHPRA. Assess and evaluate GMP inspection reports of other regulatory authorities on international pharmaceutical manufacturing sites where medicines for exportation to South Africa are manufactured. Perform pre- and post-registration inspections on information submitted in a medicine application dossier.
• Perform a once-off evaluation on information submitted by HCR (Applicants). Work closely across inspection teams, SAHPRA departments, and external regulators to ensure inspection activities are planned and communicated effectively.
• Evaluate Standard Operating Procedures (SOPs) of the Inspectorate for compliance with GMP/GWP guidelines as adopted by SAHPRA. To contribute to the Inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled appropriately. Prepare reports for SAHPRA and relevant Advisory Committees and the Finance Unit.
• Liaise with inspectors from international regulatory authorities. Assist in minuting the recommendations of relevant advisory committees of SAHPRA applicable to the activities of the Inspectorate Unit. Interview members from the industry to discuss SAHPRA Board resolutions and requirements of the Medicine and Related Substances Act, No. 101 of 1965 [and medicines quality issues.
• To provide advisory support to key stakeholders, including participation in regulatory meetings and conferences, external presentations all while demonstrating sound industry and technical knowledge. Record statistics of generated and peer-reviewed reports. Manage the associated risks and audit queries through a clear governance process, ensuring that the correct procedure is followed, care taken, and ethical behaviour demonstrated when managing inspection related resources and that all relevant records and evidence are sufficiently maintained for audit purposes.