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.
Qualifications
- Master's degree in Chemistry
- 12+ years relevant work experience in Quality Control USFDA approved manufacturing OSD facility
