Unmesh Angre is a Medical Microbiologist with more than 21 years of hands-on experience in commercial scale Quality Control and Quality Assurance roles, spanning bulk drug substances and drug products of Viral Vaccines, Bacterial vaccines, Recombinant vaccines, Recombinant Therapeutics and Rapid Diagnostic Test Medical devices. His expertise lies in Tissue Culture techniques, Immunoassays and In-vivo assays conducted on the Biological products.
His expertise extends to various aspects of Quality Management Systems, serving as a cornerstone for his capabilities. He holds the distinction of being a certified auditor for ISO 9001:2015 and ISO 13485 standards, underscoring his commitment to quality assurance. He has successfully undergone multiple audits by esteemed bodies such as WHO, DCGI, and third-party auditors, focusing on Vaccines and Rapid Diagnostic Test kits.
His profound familiarity with the tenets of Good Manufacturing Practices (GMP) regulations is complemented by his adeptness with influential guidelines, including those set forth by WHO, ICH Q5C, Q2, and other pertinent frameworks.