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:
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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