Isha Tiwari

Background

About Isha Tiwari

A 2020 Graduate from Kamla Nehru Institute of Technology, Sultanpur in Electronics Engineering. Having a total of 2+ years of experience working on Computerized System Validation (CSV) for the Life Sciences and Health Care domain for the pharmaceutical giants of the US and across the globe. Currently working as an Advisory Analyst at Deloitte USI. Specialties: Computerized System Validation for GxP/Non-GxP/SAAS system in compliance with the regulations from US-FDA 21 CFR Part 11, GAMP5 Liaise with internal teams (e.g, developers and product managers) to identify system requirements. Review and approve different SDLC Validation artifacts like Compliance Analysis, User Requirement Specification/Functional Requirement Specification, Design Specifications, IQOQ, Test Protocol, Test Report, System Admin/Application Access Procedures, Risk Assessments, and Traceability Matrix. Proficient in using testing tools like HP ALM (Application Life Cycle Management), QTest, and Jira. Review and approval of Test Scripts (System Test/ Regression Test, UAT) and Test Executions. Perform the Validation Activities throughout the Software Development Lifecycle Management process. Sound knowledge on the Agile/Waterfall Methodologies. Experienced in Risk assessments, Periodic reviews, Change management, Problem Management, Incident Management Processes, and CAPAs.