Nishodh Saxena Ph. D.

Greater Los Angeles Area, Gujarat United States

Strategic GMP Consultant at Lupin Ltd. Biotechnology Division

Medical / Health Care / Pharmaceuticals

A Quality & DRA professional with width & depth of experience spanning 25+ yrs across key functions in pharma-biotech space First-hand experience in negotiating with US FDA, CHMP and MHRA. Extensive hands on experience on all Injectable / Parenteral Dosage Forms (Prefilled syringes / Vials / Lyophilized Vials / Multi dose pen) and Solid Dosage forms. Quality management system, Design and Execution:Layout design,detailed engineering,Validation of facility,Water system, equipment,method,process,Cleaning validation,Computer/electronic System,Change control,Deviation,OOS,OOT,Investigation,CAPA,Maintenance & Preventive maintenance, Stability testing, Quality Control, Batch Control & Product...