Quality Assurance Pharmacist - External Supplier Audits
Sector: Pharmaceutical Manufacturing Industry
Location: Johannesburg
Traveling: Required to different provinces as per supplier vendor audit obligations (Own reliable Vehicle and Valid Drivers License)
Reference: QAPH – JHB – MK
Essential Requirement: Showcase estimate of 3 years proven Pharmaceutical Vendor Supplier Audit experience and Vendor Management , conducting and leading supplier audits independently within the pharmaceutical manufacturing sector e.g.: Contract Testing Laboratories, Transportation and Logistics Providers, Packaging Material Suppliers, Contract Packaging Organizations etc. experience in the above is non-negotiable.
Overall, auditing these external vendor suppliers helps pharmaceutical companies maintain control over their supply chain, mitigate risks, and uphold product quality and safety standards.
Are you a detail-oriented pharmacist with a passion for quality assurance? We're looking for a Quality Assurance Pharmacist to join our Multinational Pharmaceutical client’s team in Johannesburg and take the lead in external supplier audits. If you have a strong understanding of regulatory requirements, quality assurance principles, and experience in pharmaceutical manufacturing, this role could be for you.
Key Responsibilities:
- Quality Agreements: Initiate and maintain Quality/Service Level Agreements for all GXP Suppliers. Perform 3 yearly reviews of all SLAs and maintain the Approved Supplier list. Ensure all quality agreements are filed in a central database.
- Audits: Initiate an annual audit plan for internal and external audits, execute audits, report findings, and ensure timely closure of observations. Conduct audits of processes/departments or suppliers as necessary, and provide key involvement in corporate and regulatory audits.
- KPI Reporting & Annual Quality Management Review: Supply required inputs for KPI reporting related to Quality Assurance. Prepare slides for Annual Quality Management Review Meeting and ensure timely submission. Maintain a system for supplier evaluation and approval. Coordinate corrective actions from supplier performance reports. Conduct audits of non-compliant suppliers and maintain the Approved Supplier List.
- Standard Operating Procedures: Ensure all required SOPs are initiated, updated, trained, and current. Review and adopt relevant global SOPs locally as required.
- Quality Systems: Investigate, close, and follow up on Risk Assessments, CAPA, Change Controls, and Events to ensure timely closure and effectiveness of corrective action.
- Product Release: Review and evaluate Batch Manufacturing Records (BMRs) and Batch Release Logs (BRLs) prior to product release. Process product release transactions in a timely manner.
- General: Support Senior Quality Systems Manager/Head of Quality with related quality projects. Assist QA Document Controller with issuing Production Documents. Provide effective QA support to branches and conduct QA-related investigations as needed. Establish and maintain positive working relationships internally and externally. Ensure completion of all planned training within the timeframe.
Education: Formal Qualifications: Bachelor of Pharmacy
Skills & Experience: 2-3 years' experience as a Vendor Supplier Auditor in a Manufacturing Pharmacy. Expertise of cGMP principles, ISO 9000, quality auditing, and supplier management. Understanding of legislation for Manufacturing Pharmacy and regulatory processes.
Join us in ensuring the highest standards of quality assurance in pharmaceutical manufacturing. If you're ready to make a difference and excel in a challenging yet rewarding environment, apply now!
Supporting documents to accompany CV application:
Copy of relevant qualification/s including your Matric certificate
Copy of ID
Thank you for your attention to these requirements. We look forward to reviewing your application.
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