Job
Description
Role & responsibilities Oversee and manage the Quality Control department to ensure efficient laboratory operations. Develop, implement, and maintain QC protocols and Standard Operating Procedures (SOPs) in compliance with GMP, FDA, MHRA, and other regulatory standards. Supervise and mentor QC staff, providing training and technical support to maintain high performance. Conduct routine and non-routine testing of raw materials, intermediates, and finished pharmaceutical products. Ensure timely and accurate analytical testing, stability studies, and method validations. Investigate and resolve out-of-specification (OOS) and out-of-trend (OOT) results, implementing corrective and preventive actions (CAPA). Coordinate with Production, Quality Assurance, and R&D teams to ensure smooth manufacturing and compliance processes. Review and approve analytical data, reports, and COAs (Certificates of Analysis). Ensure proper calibration, validation, and maintenance of laboratory instruments and equipment. Manage laboratory documentation, ensuring compliance with data integrity guidelines. Participate in regulatory inspections, audits, and customer visits, providing necessary documentation and responses. Stay updated on industry trends, regulatory changes, and advancements in analytical techniques. Preferred candidate profile Bachelor's/Masters degree in Pharmacy, Chemistry, Microbiology, or a related field. Minimum 12+ years of experience in Quality Control within the pharmaceutical industry. Strong knowledge of GMP, GLP, ICH guidelines, and regulatory requirements (FDA, MHRA, WHO, etc.). Hands-on experience with analytical techniques such as HPLC, GC, FTIR, UV-Vis Spectrophotometry, etc. Experience in handling QC audits, deviations, OOS investigations, and CAPA implementation.
