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

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Job title : Specialist: Good Manufacturing Practices (GMP)

Job Location : Gauteng, Pretoria

Deadline : January 20, 2025

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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. 

How to Apply for this Offer

Interested and Qualified candidates should Click here to Apply Now

  • Production / Manufacturing  jobs