CAR-T - Quality Assurance (Sr. Executive/Assistant Manager)

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.

Full time