Sejal Hirpara

Sejal Hirpara is a professional Validation Engineer currently employed at CASI Pharmaceuticals, Inc. since July 2019, possessing extensive knowledge of GAMP 5 Regulatory guidelines and 21 CFR Part 11 Regulations related to electronic records and signatures. Key skills include preparation and review of User Requirement Specifications, Functional Requirement Specifications, validation protocols, and Risk Assessments. Prior experience as a Validation Analyst at Acorda Therapeutics, Inc. from July 2015 to June 2019 involved developing and maintaining the System Development Life Cycle for validated systems, along with a strong focus on FDA regulated environments and cGxP standards. Sejal holds a Master of Pharmacy degree from Gujarat Technological University.