Senior Officer at Shantha Biotechnics Limited,Part of Sanofi Aventis Group
Industry
Medical / Health Care / Pharmaceuticals
About
Having 6 years of experience in cGMP commercial manufacturing of Bacterial Vaccines with Quality Aspects, Fermentation(Upstream & Downstream Process). Hands on training and experience in operation of fermenters (22 L to 1800 L capacity) on SCADA platform. Successful scale up of Upstream Process (Seed development,fermentation,Clarification) for Tetanus Toxoid Vaccine production.Preparation of SOP,BPR,Process deviation,Change Control with adherence to GDP and as per QA requirements.SAT, IQ,OQ, CTP, PQ of fermenters, and process related queries. Process automation SCADA of Unit Operations (For BIOZEEN 1800L Fermenter).Process validation, equipment validation and cleaning validation of equipm...
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