3-4

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.

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

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

B.Pharma, D. Pharma. QC analyzing, Stability, In process, FP, RM sample. Handling instruments and review of analytical data. Felix Generics

M.Pharm, B.Pharm, M.Sc, B.Sc. Experience of QC documents, Specification and STP Preparation. Experience of method development, method validation and documentations

B.Pharm / M.Pharm/ B.Sc/ M.Sc. Vendor Management/ Process Validation / Audit& Compliance/ Investigation Team / Sampling/ IPQA at Micro Labs

largest lyophilized injectable plant, Gufic Biosciences. B.Pharma / M.Sc, Preference will be given to the candidates having experience of working in sterile pharma plant.