Sujan Gaire

Validation Engineer @Allogene Therapeutics

South San Francisco, CA, US

The job involves validating the Laboratory Information Management System (LIMS) and Learning Management System (LMS) modules using Veeva-Vault, HP ALM etc, following GxP and FDA 21 CFR Part 11 requirements. Responsibilities include analyzing user requirements, reviewing Requirement Risk Assessments and SOPs, authoring and executing qualification protocols (IQ,OQ,PQ), resolving discrepancies, managing Change Management using TrackWise, defining test scripts and cases, documenting the Requirement Traceability Matrix (RTM) and creating a Validation Summary Report (VSR)

Bharathiar University

Bachelor of Business Administration - BBA