About the Role
Our client, a distinguished pharmaceutical company located in the vibrant city of Cape Town, Western Cape, is seeking an experienced and highly motivated Lead Pharmaceutical Quality Control Analyst. This critical role is responsible for overseeing all aspects of quality control testing and analysis within the manufacturing process, ensuring that all products meet the highest standards of safety, efficacy, and regulatory compliance. The successful candidate will lead a team of QC analysts, manage laboratory operations, and implement robust quality systems. This position offers a fantastic opportunity to contribute to the production of essential medicines and to advance your career within a reputable organization. We are looking for a detail-oriented professional with a strong understanding of pharmaceutical quality assurance and a commitment to excellence.
Key Responsibilities
- Supervise and mentor a team of Quality Control Analysts, providing guidance and ensuring adherence to protocols.
- Develop, validate, and implement analytical methods for raw materials, in-process samples, and finished pharmaceutical products.
- Conduct and oversee routine quality control testing using techniques such as HPLC, GC, UV-Vis spectroscopy, and titration.
- Ensure compliance with Good Manufacturing Practices (GMP) and other relevant regulatory standards (e.g., SAHPRA).
- Investigate Out-of-Specification (OOS) results and deviations, implementing corrective and preventive actions (CAPAs).
- Manage laboratory equipment calibration, maintenance, and qualification.
- Prepare and review QC documentation, including test methods, specifications, and reports.
- Collaborate with Production, Quality Assurance, and Regulatory Affairs departments to resolve quality issues.
- Contribute to continuous improvement initiatives within the QC laboratory.
Requirements
- Bachelor's or Master's degree in Pharmacy, Chemistry, Analytical Chemistry, or a related scientific field.
- Minimum of 6 years of progressive experience in pharmaceutical quality control, with at least 2 years in a supervisory or lead role.
- Extensive hands-on experience with analytical instrumentation, particularly HPLC and GC.
- In-depth knowledge of GMP guidelines and pharmaceutical quality systems.
- Proven ability to develop, validate, and transfer analytical methods.
- Strong understanding of pharmacopoeias (e.g., BP, USP, EP).
- Excellent leadership, communication, and interpersonal skills.
- Detail-oriented with strong analytical and problem-solving capabilities.
- Experience with root cause analysis and CAPA implementation.
- Must be able to work effectively in a laboratory environment in Cape Town.
Benefits
- An attractive annual salary of ZAR.
- Comprehensive health insurance coverage.
- Pension fund and other retirement benefits.
- Paid time off and sick leave.
- Professional development opportunities and training programs.
- Access to modern laboratory facilities.
- A supportive team environment focused on quality and compliance.