India
I’m a pharmaceutical quality and validation expert with nearly 20 years of experience driving compliance, reliability, and operational excellence across global GxP environments. With a Master’s degree in Analytical Chemistry and an MBA in Production and Operations, I’ve led quality systems, computer systems validation (CSV), and commissioning & qualification (C&Q) functions within some of India’s leading pharmaceutical organizations—including Lupin, Wockhardt, Emcure, and Dr. Reddy’s Laboratories. My strengths span laboratory instrumentation and calibration, regulatory audit readiness, and quality risk management. I have extensive hands-on expertise with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Software testing, and global cGMP regulations, ensuring validated and inspection-ready computerized systems. Key Skills • Computer Systems Validation (CSV) • Commissioning & Qualification (C&Q) • GxP & cGMP Compliance • FDA 21 CFR Part 11 & EU Annex 11 • Quality Risk Management • Regulatory Audit Readiness • Laboratory Instrumentation & Calibration • Quality Systems & Documentation • Project Execution & Technical Strategy • Training & Capability Building • Business Development in Pharma Services • Data Integrity & Validation Lifecycle Management
computerized system validation and compliance, QMS and documentation, CSV,
computerized system validation and compliance, QMS and documentation