Anshul Gupta
Senior Associate Partner @PQE Group
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WORK HISTORY
Senior Associate Partner @PQE Group
London, GB
EDUCATION
Vellore Institute of Technology
Bachelor's degree, Electrical and Electronics Engineering
St. Paul's School
Higher Secondary Education, Science
ABOUT ANSHUL GUPTA
A result oriented Operations, Quality and Strategic leader with extensive experience in providing technical support to different Pharmaceuticals and Biopharmaceuticals customers globally with various Commissioning, Qualification, Validation and Calibration activities. Extensive experience in managing time strategic projects of qualification and technology transfer of entire facilities or specific processes at equipment, utilities, computerized systems and quality system levels in sterile/non sterile API, formulations & biopharmaceutics and medical devices for US, EMEA regulatory environments.Beyond technical expertise, I drive strategic operations, overseeing C&Q Proposals, Resource Planning, Recruitment, Project Governance, and handling Key Customer Accounts across multiple regions while enhancing operational efficiency through training and standardized processes.Project Management, Resource coordination and Budget monitoring skills consolidated through 200 + projects. Is always curious and willing to explore, improve and innovate. Considered one of the Qualification Engineers specialized in Commissioning and Qualification and Computer System Validation,U.S. Title 21 CFR Part 11 Regulation. Qualification of Process Equipment, Laboratory Equipment, Area Qualification and Clean Utilities Qualification (e.g, HVAC qualification, Process Gasses qualification, WFI / PW system qualification, Non-analytical instruments qualification and also Thermal qualification). Technology Transfer of Entire facilities or specific process at equipment, utilities, computerized system and Quality system. Designing and Drafting of Validation Life Cycle Documents used during the execution of validationactivities of critical instruments, informative systems. Handling Time Strategic projects of FDA Readiness and remediation projects for Pharma and Medical devices industries. Product and Process Critical Aspect Risk Assessment from design to the pilot/commercial phase. Involved in several projects around the globe which includes various activities of Technical Support, Project Management and Resource coordination. Monitored and met project deadlines, goals and objectives to support project management in a matrixed reporting environment.
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