Supervise day-to-day QC laboratory activities (chemical, instrumental, and microbiology where applicable).Review and approve analytical results, COAs, test reports, and raw data.Ensure compliance with cGMP, GLP, ICH, and regulatory guidelines (USFDA, EMA, WHO, etc.).Oversee calibration, qualification, and maintenance of instruments (HPLC, GC, FTIR, UV, KF, etc.).Review and update SOPs, STPs, GTPs, and analytical documentation.Manage laboratory investigations—OOS, OOT, deviations, CAPA.Coordinate method validation, method transfer, and verification activities.Ensure timely sampling and testing of RM/PM, intermediates, finished APIs, and stability samples.Support audits (regulatory & customer) and ensure readiness of QC operations.Train and supervise QC analysts; ensure adherence to safety practices.
