Requirements: 

• Applicants must be in possession of a post-matric qualification in Business Administration or similar. 

Experience: 

• 1-2 years of administrative experience in a regulated environment, a National Diploma will be an added advantage. 

Competencies, Knowledge and Skills: 

• Thorough knowledge and understanding of sound administrative and reporting requirements.
• Ability to maintain a high level of accuracy in preparing and entering information and attention to detail.
• Report writing.
• Excellent interpersonal skills and communication skills (written and verbal).
• Critical thinking and the ability to exercise good judgement and solve problems quickly and effectively.
• Computer skills.
• Time management skills.
• Problem-solving skills.
• Client orientation and customer focus. 

Duties:

• Prepare report to be sent to evaluators of pharmaceutical manufacturing sites for compliance with Good Manufacturing Practices (GMP).
• Prepare resolutions for Pharmaceutical Products as accepted by SAHPRA.
• Work closely across inspection teams, SAHPRA’s units 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.
• Contribute to the Inspectorate’s compliance management process by ensuring that instances of suspected or known non-compliance are handled in an appropriate manner.
• Prepare reports for SAHPRA’s Finance Unit. Liaise with inspectors within regulatory authorities.
• Interview members from the industry to discuss SAHPRA Board resolutions and requirements of the Medicine and Related Substances Act, 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 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.