Vishal Sharma is Masters in Microbiology, and is member of the group that provides technical and practical support to the biopharmaceutical industry in India. He has played a hand in helping many organizations grow and change, especially in the oncology research/development, scale-up, production, monitoring and validation. He is a pioneer in domains of aseptic process review and optimization in India. Vishal has been instrumental in providing valuable support to many biopharmaceutical industries in areas of regulatory compliances- from identifications of equipment and process suppliers/vendors to adopting cGXP practices for organizational technical and process capacity building.
He was one of the core members to set up first filter validation lab in India and second in Asia, He had the prestige of being a certified microbiologist in India to perform studies related to filter validation, for the submission of supporting documents for regulatory dossiers.
His earlier years of being in the pharmaceutical industry in microbiology help him in being a good solution provider to Microbiology Functions, especially in sterile API & DP with his exposure to facing regulatory audits. This experience brings value to the various discussions that he has during the training that he conducts for microbiologists in pharma and biotech organizations, from research and development to manufacturing process monitoring.
With years of being in the biopharmaceutical and allied industry, Vishal is committed to supporting and strengthening the systems approach that has been used in biopharmaceutical organizations especially in the microbiology and aseptic areas, where he helps with optimization, rationalization, change, governance, strategic planning, team building, leadership development, and conflict management.
Specialties: Vishal has a deep interest in the impact of an organization’s process optimization on its culture, with a particular emphasis on the effects of return on investment in aseptic processing, microbiology & sterilization.