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...
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