Regulatory Compliance Pharmacist
7 days ago
Pharma Dynamics Ltd is seeking a highly skilled Quality Assurance Pharmacist to join our team in the Western Cape.
About the Role:We are offering a competitive salary of approximately R850,000 per annum.
Key Responsibilities:- Contribute to the development and implementation of best practice processes and procedures to enhance operational efficiency and ensure timely product release to market.
- Coordinate batch release reviews and approve final product release in accordance with legal requirements and guidelines set by SAHPRA and the Department of Health.
- Maintain and coordinate GMP principles as required by SAHPRA, ensuring compliance with the latest version of the SAHPRA/PIC/S guidelines.
- Liaise with relevant 3rd parties to ensure all pre-requisites are available for product release.
- Process SAP releases and amendments, including batch creation and updates.
- Ensure direct communication and continuous pursuit of achieving annual plans and schedules, including stability plans, product quality reviews, and quality agreements.
- Liaise and communicate anomalies, non-compliances, and discrepancies to the team and assist with deviations and investigations.
- Capture accurate data across all electronic platforms.
- Assist with product-related GMP activities, including stability, annual product quality reviews, quality agreements, audits, and risk assessments.
- Review executed Batch Manufacturing documents received from 3rd parties.
- Assist in product recalls/mock recalls.
- Control Head office sample storage and ensure S6 and SS5 registers remain balanced at all times.
- Maintain in-house documentation relating to QA processes, ensuring compliance with current SAHPRA licensing conditions.
- B. Pharm registration with the SA Pharmacy Council.
- Minimum 2 years Quality Control or Quality Assurance experience within the pharmaceutical industry.
- Knowledge of the quality environment within the pharmaceutical industry.
- Working knowledge of cGMP and Quality Management Systems.
- Understanding of batch release requirements and processes.
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