4-5

Expected M.Pharm by education with 3+ years experience for Document requisition and review, Dossier Preparation, CTD, ACTD, Country specific for ROW Market

Knowledge & hands-on experience of equipment qualification & validation of sterile manufacturing of USFDA approved sterile facility only.

Knowledge of injectable plant aseptic practices, BMR, PFS Filling, Cartridge Filling, Lyophilization, SVP/LVP Line etc.

Hands-on experience with analytical instruments such as Particle Size Distribution (PSD) analyzer (Malvern), Zeta Sizer, and Dissolution Apparatus I, II, and IV will be considered an added advantage.

Coordinate method development and validation for trace-level nitrosamine detection using LC-MS/MS.

Packing Material | Raw Material | Receipts | Dispensing | Storage | Finishing Goods

Change Control Management, Deviation Management, Quality Risk Assessment. EU, MHRA, USFDA & ANVISA audits / regulatory exposure is MUST required

Sterile dosage form product development, execution and CMC submission experience for regulated markets is basic requirement.

Analytical Method Validation, HPLC - Dissolution, GC. and Analytical data review, QMS. RM & PM testing.