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Bhavesh Patel is an experienced professional specializing in GxP IT and Computer System Validation (CSV) with a robust background in quality management systems. Currently serving as Associate Director of CSV Quality Management Systems at Amicus Therapeutics since August 2021, Bhavesh has been pivotal in standardizing validation activities across Global GxP Applications. Bhavesh's extensive tenure at J. Knipper & Company, Inc. since January 2011 includes roles as GxP IT POD Lead/Manager, where leadership in cloud-based application development and validation ensured IT quality and compliance with GxP regulations. Previous positions held include Validation Lead and Sr. Validation Analyst, emphasizing expertise in FDA regulatory compliance and comprehensive validation documentation. Bhavesh holds a Master of Science degree from the Illinois Institute of Technology and a Bachelor of Engineering degree from Nirma Institute Of Technology.