Specialist: Good Manufacturing Practices (GMP) at South African Health Products Regulatory Authority

Key Responsibilities include but are not limited to: 

• Conduct GMP Inspections: Lead local and international pharmaceutical manufacturing site inspections, ensuring compliance with GMP standards adopted by SAHPRA. 
• Policy Development and Advisory: Shape GMP-related policies, guidelines, and inspection frameworks in line with global best practices. 
• Global Engagement: Collaborate with international regulatory bodies and represent SAHPRA in global regulatory forums and conferences. 
• Capacity Building: Provide training, mentorship, and capacity development on GMP regulatory practices for SAHPRA staff and stakeholders. 
• Risk Management: Ensure ethical, accurate, and efficient management of inspection-related risks, resources, and records. 

Performance Expectation include but are not limited to: 

• Demonstrate strong leadership qualities in a regulatory environment. 
• Excellent communication, analytical, and decision-making skills to navigate complex challenges. 
• Implement effective risk management strategies to mitigate potential risks and ensure the quality and safety of pharmaceutical products. 
• Thrive in a dynamic and multicultural environment while working effectively within diverse teams. 
• Adapt and manage competing priorities efficiently. 
• Conduct thorough inspections of local and international pharmaceutical manufacturing sites to verify adherence to SAHPRA's GMP standards. 
• Consistently identify and document GMP deviations and compliance issues, and issue inspection reports that are accurate, timely, and well-supported by evidence. 
• Play a key role in developing and implementing GMP-related policies, guidelines, and inspection frameworks. 
• Transfer skill to SAHPRA staff and stakeholders on GMP regulations and inspection procedures. 
• Contribute to capacity development initiatives to enhance GMP expertise within the organization. 
• Adhere to South African data protection laws and SAHPRA's specific data protection policies 

Application Criteria: 

Qualifications and Expertise 

Essential: Master’s degree in Pharmacy. 

• Registration as a Pharmacist. 
• A minimum of 10 years of experience in pharmaceutical manufacturing or quality management systems (QMS), including GMP inspections. 
• Proven technical leadership in regulatory environments and participation in international regulatory forums or advisory bodies. 

Preferred: A PhD in a related field. 

• Demonstrated experience with hybrid or remote international collaboration.