Mr. Amit SME Pharmaceutical Analysis
Having a rich and progressive experience of more than 22 years in pharmaceutical analytical research and quality control. Has worked in API and new drug discovery. His experience includes in hormones manufacturing facility. Mr. Mishra has worked in big pharma companies like: Ranbaxy, Jubilant, Lupin and Morepen Laboratories approved from regulatory agencies USFDA, EU GMP, TGA, Health Canada and many more.
- Familiar with statutory regulations; EU-GMP vol.4- Part I and 2, CFR Part 211 , ICH Q7 and Schedule M
- Quality risk management as per ICH Q9
- Analytical Method Development and validations
- Acquaintance with computer system validation