Selvam Pappunathan
Bengaluru
Summary
- Extensive experience in Computer System Validation (CSV), managing the complete validation lifecycle for critical GxP applications in the pharmaceutical and life sciences sectors.
- Strong knowledge of global regulatory frameworks, including FDA, EU guidelines, 21 CFR Part 11, and GAMP 5, ensuring validated systems meet all compliance requirements for GxP environments.
- Proven ability to prepare and review qualification documents such as software/equipment categorization, URS, risk and GxP assessments, validation plans (DQ, IQ, OQ, PQ), and summary reports.
- Demonstrated expertise in developing, executing, and maintaining validation protocols and test cases, as well as compiling test results and ensuring traceability to user requirements.
- Experienced in using electronic validation lifecycle management systems (e.g., ValGenesis, eVLMS and TIMS) to execute, document, and manage validation deliverables efficiently.
- Skilled in performing manual and automated audit trail reviews, and periodic reviews of scientific and business-critical applications to support data integrity and regulatory inspection readiness.
- Adept at risk-based validation strategies, system risk assessments, and collaborating cross-functionally with QA, IT, and business stakeholders to ensure validation deliverables meet both regulatory and business objectives
Overview
8
8
years of professional experience
5
5
years of post-secondary education
1
1
Certification
Work History
IT Validation and compliance analyst 2
Novo Nordisk service india private limited
Bengaluru
05.2024 - Current
- Involved in the initiation and scoping of ITRA during the project phase, including scoping within ServiceNow IRM for auto-generated relevant controls, performing risk evaluation and control mapping, and collaborating with central risk managers, QA, GIS advisors, and IT risk owners; also acted as Risk Manager for reviewing and approving ITRA and associated controls.
- Lead the Infrastructure Services team, overseeing the preparation of annual user review documentation and ITPSE compliance reports.
- Directed validation planning, deliverable preparation, and execution for critical GxP projects, ensuring full compliance with QA standards and business application requirements.
- Spearheaded automation initiatives for user review reporting to improve efficiency and accuracy.
Senior Executive
Biocon biologics limited
Bengaluru
06.2020 - 05.2024
- Gained exposure in the preparation and review of qualification documents, including Software and Equipment Categorization, URS, Risk Assessments, GxP Assessments, Validation Plans, DQ, IQ/OQ/PQ protocols, and Validation Summary documentation. Executed activities within eVLMS and performed manual audit trail and periodic reviews of scientific applications.
- Prepared and executed validation protocols, compiled test reports, and contributed to CSV deliverables by assisting, authoring, and reviewing documents such as Validation Plans, Test Plans, and Summary Reports.
- Perform system risk assessments and review action plans to ensure compliance during and after the system validation.
Senior Associate
Mylan laboratories
Hosur
04.2017 - 06.2020
- Exposure on greenfield project
- Computerized equipment qualification
Education
Master of Science -
VIT University
Vellore 04.2012 - 06.2014
Bachelor of Science -
PKN Arts And Science College
Madurai 04.2009 - 04.2012
Skills
- Computerized system validation
- GxP systems & software integrated equipments
- IT Risk assessment & ITRA Facilitation
- Compliance consulting & Quality coordination
- Stakeholder management & collaboration
- Service delivery & evaluation
Certification
- Completed 60 days course on computerized system validation from pharma connections
- Certified in ISO 9001-2015 from Alison.
- AI essentials for industry professionals from koeing Solution Pvt.Ltd.
Timeline
IT Validation and compliance analyst 2
Novo Nordisk service india private limited
05.2024 - Current
Senior Executive
Biocon biologics limited
06.2020 - 05.2024
Senior Associate
Mylan laboratories
04.2017 - 06.2020
Master of Science -
VIT University
04.2012 - 06.2014
Bachelor of Science -
PKN Arts And Science College
04.2009 - 04.2012