Rakesh Sharma is a trained Microbiologist, boasts over 22 years of experience in commercial scale manufacturing and Quality Assurance activities of bulk drug substances and drug products of vaccines including recombinant vaccines, baby products and medical devices. He has hands-on in creating Pharma products, baby creams, and oils.

He’s a pro at purifying proteins and excels in Quality Management, Technology Transfer, Facility checks, audits, rule adherence, and GMP training. He holds the distinction of being a certified auditor for ISO 9001:2015 standards, underscoring his commitment to quality assurance and has handled WHO, DCGI, and third-party audits.

He has Profound acquaintance with Good Manufacturing Practices (GMP) and pertinent regulations/guidelines such as WHO, ICH Q7A, 21 CFR Part 21, among others.