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- Review of qualification (IQ, OQ & PQ) documents related GMP Mfg. facility for Cell & Gene Therapy products.
- Initiation, review, assessment, verification, closure of qualification related QMS (Change Control, Deviations, CAPA, Discrepancies, risk assessments etc.).
- Review of qualification protocols for clean room qualification, HVAC systems and support users for execution of qualification activities.
- Review of qualification protocols for equipment/instruments for DQ, IQ, OQ, PQ and support users for execution of qualification activities.
- Involve in qualification/re-qualification activities of BSC, Deep Freezers, HVAC, process equipment, Utilities,
- Review of Master Equipment List, various planners (calibration, PM, re-qualification/validation)
- Support for Qualification Engineering Service providers.
- Review of executed PM, calibration, and re-qualification documents.
- Review process validation and process simulation (media fill) protocols and reports.
- Review and provide support and guidance for CSV documents and activities.
- Participate and support for technology transfer projects.
- Support for all internal and external audits.
CAR-T - Quality Assurance (Sr. Executive/Assistant Manager) - Bengaluru, India - Aurigene Oncology Limited
