Vikas rana
Vikas Rana is an FDA-approved Microbiologist with 17 years of extensive experience in pharmaceutical microbiology and quality control. He currently serves as the Assistant General Manager of Microbiology at Ceph Lifesciences, where he leads microbiology operations and compliance across four formulation and API plants. His technical expertise encompasses the full spectrum of microbiological testing for sterile and non-sterile products, including sterility validation, bacterial endotoxin testing, microbial limit tests, and environmental monitoring. He has a proven track record in managing OOS and incident investigations, qualifying laboratory instruments (IQ, OQ, PQ), and executing robust water validations and media fills. Holding an M.Sc. in Microbiology from H.N.B Garhwal University, he has successfully faced numerous stringent international audits, including USFDA, MHRA, TGA, ANVISA, and EU GMP. He leverages this deep regulatory experience and practical laboratory leadership to deliver comprehensive, compliance-focused training in pharmaceutical microbiology.
Experience
17+ Years
Dexterous Microbiologist with 17 years of experience leading microbiology laboratories and ensuring strict regulatory compliance for sterile and non-sterile pharmaceutical products.
Industry Background
Pharmaceutical Microbiology and Quality Control
Progressed through microbiology roles at Fresenius Kabi Oncology, Sentiss Pharma, and Dr. Reddy's Laboratories (serving as Team Leader for over 12 years), and currently holds the position of AGM Micro at Ceph Lifesciences.
Academic Background
M.Sc. in Microbiology
Earned an M.Sc. in Microbiology from H.N.B Garhwal University and a B.Sc. from Himachal Pradesh University.
Areas of Contribution
Pharmaceutical MicrobiologyRegulatory Affairs