QA

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.

QMS investigation, OOS, OOT, Incident, deviation, CAPA, deviation, etc., Instruments HPLC, GC, KF, UV, IR, etc

Experience required in Sterility Testing Bacterial Endotoxin Test (BET), Bioburden testing water testing.

SCIENCES OR PHARMACY GRADUATES (B.SC./M.SC./B. PHARM./M. PHARM.) WITH 0 TO 5 YEARS EXPERIENCES IN PARENTERAL MANUFACTURING.