Specialist: Good Manufacturing Practices (Gmp)

Details of the offer

Job title : Specialist: Good Manufacturing Practices (GMP) Job Location : Gauteng, Pretoria Deadline : January 20, 2025 Quick Recommended Links Jobs by Location Job by industries 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.  Production / Manufacturing  jobs


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