At Tata Consultancy Services, I direct global CSV and GxP validation programs for pharmaceutical clients. I directed a $130M SAP S/4HANA implementation and validation program that was delivered four weeks ahead of schedule with zero critical audit findings.
I designed AI-driven validation assistants and RPA automation that reduced validation cycle time by 40% and documentation effort by 35%. I also applied Generative AI and Agentic AI to solution design and validation documentation, and to generating test cases, protocols, and reports.
At PricewaterhouseCoopers (PwC), I managed CSV engagements for global pharma and biotech clients and led validation of SAP GBT, Intelligent Certificate Generation System, and SAP BTP. Those engagements had zero critical observations across three regulatory inspections.
Earlier, I worked on validation and quality across pharmaceutical and life sciences organizations, including LIMS, ERP, MES, SAP ECC, chromatography data systems, and analytical instruments. My research work also included analytical method development and validation, with 50+ research papers and white papers published.
