Manshi Patel Merck & Co., Inc.

Manshi Patel is an Associate Director at MMD Merck &Co, Inc, working in Global Microbial Quality Sterility Assurance (MQSA) based out of West Point PA. Provides support to the Sterile manufacturing, Low Bioburden and Non-sterile sites as well as CMO sites to address any compliance and quality risks. Leads global initiatives for process and continuous improvements. Responsible for providing sterility assurance and microbial contamination control to resolve critical issues related to manufacturing operations and develop standards and guidance to align with industry and regulatory expectations. Assist manufacturing sites with regulatory interactions, development of responses to inspection observations and QMS compliance. Business process owner for the global aseptic program and Microbial Control Contamination community of practice lead for Merck. She presented at the 2019 PDA microbiology Forum on “Glove Management Control Strategy”. Has 20 plus years of experience in the pharmaceutical industry with her expertise in Investigation excellence, barrier systems, environmental monitoring, risk assessments, aseptic training, and contamination control.