Manager - Quality Control

Purpose: To lead Quality Control operations ensuring cGMP/cGLP compliance, data integrity, timely testing, and batch release while maintaining audit readiness.Key Responsibilities Lead and manage all QC activities in accordance with approved SOPs and regulatory requirements. Approve job descriptions, assign responsibilities, and develop QC team members through training. Review and approve analytical documentation ensuring cGMP, cGLP, ALCOA++ compliance, and data integrity. Prepare, review, and approve QMS activities including OOS, OOT, Deviations, Change Control, CAPA, and Incidents. Ensure proper sample receipt, testing, review, approval/rejection, and timely batch release to meet SLAs and dispatch plans. Plan and allocate resources for testing of RM, IP, Bulk, FG, Validation, Stability, and external lab samples. Ensure specifications, STPs, worksheets, protocols, reports, and CoAs are current, controlled, and approved (LIMS/manual). Ensure QC laboratory is maintained in an audit-ready condition at all times. Oversee calibration, verification, AMC, and qualification of all QC instruments prior to use. Ensure control and validity of standards, reagents, volumetric solutions, chemicals, and reference materials. Coordinate with cross-functional teams, customers, and external laboratories for smooth operations and project transfers. Prepare monthly QC performance reports and manage QC OPEX and CAPEX budgets. Ensure safe, compliant, and environmentally responsible laboratory operations including gowning/de-gowning practices.QualificationsMaster's degree in Chemistry 12+ years' relevant work experience in Quality Control USFDA approved manufacturing OSD facility

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