Nanda Kishore

Background

About Nanda Kishore

M.Sc, Biochemistry with 13 years of experience in Upstream Processing Vaccine Production and QMS lead, Projects, Validations and Quality Systems. Hands on experience in Various microbial production (Pichia Pastoris, E.Coli), Cell culture production (MRC-5, CHO) and Virus culture production (Measles, Rubella). Handling different types of Single use bioreactors, Conventional Fermenters, Continuous Centrifuge, Depth filtration, Autoclaves BSC, LAFs, Aseptic techniques etc. Filing Change Control, Deviation and performing investigation and taking extraordinary CAPAs. Planning and Organizing projects like GMP facility modifications and new facility design according to regulatory requirements. Great knowledge on Preparation of Risk assessement by using FMEA and FMECA tools. Preparation URS and performing DQ, FAT, SAT, IQ, OQ and PQ. Performing Validations/Revalidations, Commissioning and Qualifications for facility, Equipment, Process and Cleaning. Facing Regulatory Audits and to provide CAPAs for effective implementation. Managing peoples and Shifts for continuous production to reach the production targets and management goals. Impart trainings and Perform internal and external (Vendor) audits.