Nikhil Jain

Background

About Nikhil Jain

I am experienced and detail-focused IT professional with 19+ years of experience in end to end Computer System Validation (CSV) activities for cloud based, internally developed and SaaS IT Systems in accordance with GAMP 5, 21 CFR Part 11, EU Annexure 11. I maintain expertise in current and emerging compliance requirements and quality trends. An efficient team player, able to work independently to solve problems and lead qualification efforts with my strong analytical and communication skills in managing/delivering on complex topics. Have a flair to learn and adopt new practices around the software validation approach in a fast-paced, competitive, and challenging environment. Professional Skills • Computerized System Validations (CSV) • GAMP-5, FDA 21 CFR Part 11, Annex-11 • System Assessments (GxP, 21 CFR) • Risk Assessments (IT, Security, Data Integrity) • Change, Incident and Problem Management • CAPA, Deviations Management • Good documentation and Test Practice • Cloud Software Validation,