An exciting opportunity has arisen for a Quality Control Manager to lead and oversee the Quality Control (QC) Laboratory within a fast-growing pharmaceutical and custom manufacturing company. The successful candidate will manage daily laboratory operations, ensure full compliance with regulatory standards (GMP/GLP), and drive quality excellence across all testing and analytical procedures.
Key Responsibilities
- Laboratory Leadership: Manage and direct the daily operations of the Quality Control Laboratory, ensuring efficient testing of raw materials, in-process samples, and finished products.
- Compliance & Quality Standards: Ensure all laboratory activities strictly adhere to cGMP, cGLP, ISO, and relevant international regulatory standards.
- Team Management: Supervise, train, and mentor a team of QC Analysts and Technicians, fostering a culture of high performance, accountability, and continuous improvement.
- Method Validation & Testing: Oversee analytical method transfer, validation, and routine testing (e.g., HPLC, GC, wet chemistry, stability testing).
- OOS/OOT Investigations: Lead investigations into Out-of-Specification (OOS) and Out-of-Trend (OOT) results, implementing effective Corrective and Preventive Actions (CAPA).
- ocumentation & Audits: Review and approve laboratory protocols, SOPs, specifications, and test reports. Participate actively in external regulatory inspections and internal quality audits.
- Equipment & Instrumentation: Ensure qualification, calibration, and maintenance of all laboratory equipment and analytical instruments.
Requirements
- Proven experience in a supervisory or managerial role within a Quality Control Laboratory.
- Solid background in the pharmaceutical, biotechnology, or chemical manufacturing industry.
- Deep knowledge of cGMP, cGLP guidelines, standard analytical techniques (HPLC, GC, UV-Vis, dissolution, etc.), and laboratory safety protocols.
Education and experience
- Bachelor’s or Master’s degree in Chemistry, Pharmacy, Pharmaceutical Sciences, or a closely related scientific field
