M.Sc. (Biotechnology/Microbiology), M.Pharm./B.Pharm./B.Tech/B.Sc. (Chemistry) ; 2 to 10 years of relevant experience in Biologies / Biopharmaceuticals.
Having knowledge of Analytical Method Validation, Verification & Method Transfer, Handling skill for data interpretation, troubleshooting, Pharma knowledge of Solid as well as Quality processes, USFDA, MHRA, ANVISA & other regulatory exposures is preferred, including ICH guidelines.
Bachelors degree in Life Sciences, Pharmacy, Medicine. experience in Pharmacovigilance PV within the pharmaceutical or biotech industry. Proven hands-on experience in PV operations e.g., case processing, signal detection, risk management, safety surveillance
Operation, calibration, and maintenance of GC, HPLC, and analytical instruments. Analysis of raw materials, finished products, cleaning samples, and stability samples.
Formulation analytical method development using LCMS/MS, preferably using Waters make. Formulation analytical method development using HPLC/GC/IC/Potentiometry.
Experience into Operation of Vial Filling & Sealing / M/c With CRAB / Autoclave / Tunnel / Vial Washing Operations with IPC / Media Fill / Lyophilization