Manage day-to-day operations of the QC laboratory, ensuring adherence to cGMP, GLP, and regulatory requirements. Review and approve analytical data, laboratory records, specifications, Certificates of Analysis (CoA), and test reports. Supervise testing of raw materials, packing materials, intermediates, APIs, cleaning validation, water samples, and stability samples. Ensure timely calibration, qualification, preventive maintenance, and utilization of laboratory instruments. Oversee analytical method verification, method transfer, validation support, and troubleshooting activities. Investigate laboratory deviations, Out of Specification (OOS), Out of Trend (OOT), atypical results, and implement effective CAPA. Ensure compliance with ALCOA+ principles and maintain data integrity in all laboratory activities. Review analytical documentation for completeness, accuracy, and regulatory compliance. Coordinate laboratory investigations with QA, Production, Engineering, and R&D departments. Plan laboratory resources, manpower allocation, and testing priorities to meet production timelines. Ensure availability of laboratory chemicals, reagents, reference standards, columns, and consumables. Monitor laboratory KPIs such as sample turnaround time, OOS, OOT, calibration compliance, and instrument utilization.
