Software Validation Analyst
Regeneron
May 2023 - Current (3 years 5 months)
• Analyzed User and Functional Requirements Specification Documents, Design documents for test script preparation, pre and post-review of test scripts against URS and FS
• Implemented & supported global and site-specific projects i.e., managing both internal (On-premises) and external hosted systems (Cloud).
• Hands-on experience as Valgenesis Super user, Optimized Validation Processes: Streamlined equipment qualification (IQ/OQ/PQ) and computer system validation (CSV) processes through ValGenesis, reducing document management time by 40% and improving approval cycle efficiency by 35%. Developed & Maintained Validation Protocols: Created and customized validation templates and workflows within ValGenesis.
• Led data migration