Aarthi Thavasilingam

Background

About Aarthi Thavasilingam

Working as a Validation Expert in Life Science Environment (Pharmaceutical Company) 1. Currently providing Project/Application management and support 2. Trained in Computer System Validation 3. Doing Validation (Quality and Compliance) for Computerized GxP systems based on 21 CFR PART 11 and GAMP5 4. Area of Expertise - Computer system validation strategy - Requirements documentation - Complexity and risk analysis - Creating a detailed test plan based on risk - Supplier qualification - IQ, OQ and PQ - Manufacturing (Serialization and Aggregation - Lab ware Systems - CAPA management - Audit Systems - Change Control - Quality Risk Management 5. Member of a Change Advisory Board 6. Learned Automation Testing and Performance Testing 7. Familier with documentations such as- Requirements - Traceability matrix - Testing documents - Installation documents - Validation Documents - Recovery and Migration documents 8. Worked in IT deviation management and acted as an IT compliance investigation Lead/Co-ordinator who will take care of an IT deviation process end to end. Review and processing of the IT quality deviation and deviation requests. Mentoring teammates and quality review of deviation reports and CAPA’s 11. Supporting client with UAT testing for IT risk management and Quality compliance team’s applications. ITGC control mapping with SOC1 reports and reviewing the SOC1 reports to identify the Gaps 13. Provided the guidance to set ITGC controls such as Change Management, Application Management and Operational Controls in a New SAP system.