Sheetal Sehrawat

Computer System Validation (CSV) Analyst with experience supporting enterprise pharmaceutical applications in regulated GxP environments within a large-scale IT consulting context. Skilled in leading validation activities across major, minor, and emergency release cycles; authoring IQ, OQ, UAT, and Validation Summary Reports; and maintaining audit-ready documentation in ValGenesis. Adept at collaborating across cross-functional teams to deliver compliant software releases on schedule for regulated clients.

Computer System Validation (CSV) Analyst - Tata Consultancy Services (TCS) - Noida

(2024-08)

• Lead validation activities for major, minor, and emergency change requests across 4 enterprise pharmaceutical systems, supporting 10+ release cycles from impact assessment through production release in regulated GxP environments.
• Author and maintain Validation Plans, Validation Summary Reports, IQ, OQ, UAT, and System Testing documentation along with complete traceability records.
• Execute functional validation, regression testing, system testing, and UAT; document and verify defects throughout the testing lifecycle.
• Manage validation workflows and approvals in ValGenesis, maintaining audit-ready documentation at all stages.
• Remediated audit findings for a previously non-compliant validated system, resolving gaps in validation documentation to bring the system into full regulatory compliance.
• Conduct impact assessments and ensure ongoing compliance with organizational SOPs and applicable regulatory standards.
• Support migration and decommissioning of validated systems, maintaining data integrity and compliant retirement activities.
• Collaborate with business analysts, developers, QA teams, and stakeholders to coordinate compliant software releases.

Bachelor of Science - Computer Science - IIMT College of Science and Technology (2024)