Quality Assurance Pharmacist

SUMMARY:
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POSITION INFO:

We are seeking a Quality Assurance Pharmacist to ensure products comply with local and international quality assurance standards, safeguarding legal compliance.

Ensure compliance with SA requirements (SAHPRA and SAPC) and quality requirements as prescribed by GMP, GWP, and the Afrigen Quality system.

Key Responsibilities

• Maintain up-to-date knowledge of the relevant legal requirements and GMP/GDP regulations.
• Release clinical trial product batches to the CRO, ensuring compliance with the local regulations, Afrigen guidelines and the CTA.
• Ensure that all relevant GMP/GDP processes are described in current Standard Operating Procedures and are adhered to correctly.
• Perform self-inspections
• Use the change management system to initiate, assess and approve relevant GMP/GDP changes prior to implementation.
• Handle complaints, recalls and returns according to Pharma Quality System and local SOP's.
• Compile annual quality product reviews, according to SOP.
• Action corrective actions, preventative actions and recommendations as per audit reports, self-inspections, discrepancy remediation, and complaints remediation to ensure continual improvement.
• Perform quality risk assessments, establish risk controls and review risks to assist with the Quality Risk management process.
• Ensure that all GMP-related documentation is handled correctly and is readily available

Qualification and Experience

• Bachelor of Pharmacy (B.Pharm) degree
• Registered with the SAPC
• 5 years’ experience in the pharmaceutical industry
• Experience in a regulatory capacity, ideally in a SA regulatory environment, which includes licensing of products in a manufacturing context (advantageous)
• Experience as a Responsible Pharmacist in an Applicant company ora  Manufacturing Pharmaceutical company with their own portfolio of registered medicines (advantageous)
• Excellent communication and interpersonal skills