Job Summary: The Quality Assurance Pharmacist will oversee all key elements of the Quality Management System (QMS) and ensure its effectiveness in maintaining high-quality standards in compliance with GxP regulations. This role involves coordinating with other departments to foster a robust Quality Assurance culture, ensuring the continuous improvement of quality standards, and providing guidance as required. The QA Pharmacist will report directly to senior management and is responsible for maintaining all quality assurance arrangements.
Key Responsibilities: - Quality Assurance:
- Review, revise, and update all departmental Standard Operating Procedures (SOPs).
- Manage QA departmental functions including document control, quality manual, site master file, and validation master plan.
- Approve and manage the list of approved suppliers.
- Conduct internal and external audits, following up on any deviations.
- Liaise with service providers on QA matters.
- Handle non-conformance documentation and investigations, including root cause analysis and corrective actions.
- Provide support for Adverse Drug Reaction (ADR) cases.
- Oversee process and method validations, product quality reviews, and quality management reviews.
- Ensure the implementation of a stability master plan and quality risk management.
- Ensure adequate pest control and approve specification sheets for release.
Complaints: - Ensure product quality complaints are correctly identified, investigated, and addressed.
Recalls: - Ensure all batches of medicine are batch traceable in the event of a recall.
Returned/Rejected Goods: - Ensure returned goods are handled properly, and reasons for returns are documented.
- Manage the decision process for returned or rejected goods, including re-analysis, re-packing, or destruction.
GMP/GWP/GHP: - Conduct inspection audits on third-party contractors to ensure compliance with approved GMP and manufacturing procedures.
- Verify that products meet the specifications of the registration dossier and maintain quality during storage and transport.
- Oversee that logs (e.g., temperature control, cleaning) are maintained by distribution/warehousing facilities.
- Ensure the proper disposal of medicines and an effective pest control program is in place.
- Perform self-inspection/internal audits and follow up on deviations.
- Audit all external service providers as per the procedure.
Secondary Duties: - Training:
- Monitor that employees across departments are trained to implement and maintain GxP and SOPs.
Requirements: - Education: B. Pharm degree, registered with the South African Pharmacy Council.
- Experience: Minimum 5 years of QA experience, including SOP and master QA document compilation/control.
- Skills: Strong communication skills, ethical behavior, team collaboration, customer focus, ability to work under pressure, attention to detail, and good analytical skills.
- Knowledge: Knowledge of cGxP regulations and thorough understanding of the South African Regulatory Environment.
- Other: Good computer literacy and bilingual in English and Afrikaans.
