QA

Equipment qualification - Autoclave qualification, vial washing machine qualification, tunnel qualification, filling machine qualification, UAF, Mobile cart & DPB qualification.

USV Private Limited is an Indian multinational pharmaceutical and biotechnology company in Mumbai.

Follow safe work processes and ensure safety appliances are utilized during Production activities to create safe working environment. Should have good knowledge of cGMP, WHO.

To review of Smoke study protocol, report and Video recording. To authorize the final document approval in absence of Head Quality Assurance.

Having Injectable Experience of Shop floor activities like Filtration, Filling, Sealing, Stoppering, Garment Washing, Vial Washing, Autoclave, Ophthalmic, Suspensions, Lyophilizes.

Coordinate with QC/QA teams for timely document updates and Support audit/inspection readiness with proper documentation

Timely review of Batch Process and Control Records, Validation protocol / reports, Calibration, Qualification protocol / reports & Trend analysis data

In-depth knowledge of cGMP, WHO, ISO, USFDA, and other applicable regulatory guidelines. Strong leadership in QMS implementation, audit management, and team building.

M.Pharm / B. Pharm / M.Sc. / B.sc /BE/ B.tech ; preventive maintenance and breakdown - FBD, FBP, RMG, coating, compression, capsule, Packing machine etc.