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