Tapan Patel
About Tapan Patel
Tapan Patel serves as the Associate Director of QA GMP at Insmed Incorporated, bringing extensive experience in quality assurance and compliance within the pharmaceutical industry. He has held various roles in reputable organizations, focusing on sterile techniques, quality management systems, and regulatory compliance.
Current Role at Insmed
Tapan Patel currently serves as the Associate Director of QA GMP at Insmed Incorporated, a position he has held since 2021. In this role, he is responsible for overseeing quality assurance processes and ensuring compliance with Good Manufacturing Practices (GMP). His expertise in sterile aseptic techniques and tablet manufacturing significantly contributes to the company's quality management efforts.
Previous Experience at Insmed
Prior to his current role, Tapan Patel worked at Insmed Incorporated as a QA Manager - CDMO from 2018 to 2021. During this time, he managed quality assurance operations for contract development and manufacturing organizations, focusing on maintaining compliance with regulatory standards.
Professional Background in Quality Assurance
Tapan Patel has extensive experience in quality assurance, having held various positions in the pharmaceutical and manufacturing sectors. He worked as a Lead Quality Specialist and Canada QA Head at Baxalta from 2015 to 2018, and as a Quality Specialist at Baxter International Inc. from 2008 to 2015. His roles involved managing compliance documents and batch folders for regulatory reviews by agencies such as the FDA and EMA.
Educational Qualifications
Tapan Patel holds a B.Sc. from the University of Mumbai, which he completed from 1998 to 2001. He furthered his education with a Post Graduate Diploma in Pharmaceutical QA & QC from the Toronto Institute of Pharmaceutical Technology, completed in 2005. Additionally, he achieved a Lead Quality Auditor Certification – ISO9001:2015 from The British Standards Institution in 2016.
Certifications and Specializations
Tapan Patel is certified as a Quality Auditor by both the American Society for Quality (ASQ) and ISO, reflecting his strong foundation in quality standards and auditing. He specializes in drugs and dyes, which enhances his capabilities in pharmaceutical quality assurance, particularly in developing and implementing Quality Management Systems for various products.