Ankur Gupta

WORK HISTORY

EDUCATION

ABOUT ANKUR GUPTA

Experienced Quality Assurance Professional | Regulatory Compliance Expert | Pharma Industry LeaderI’m a results-driven Quality Assurance specialist with over 15 years of progressive experience in the pharmaceutical industry, currently serving as Deputy Manager – QA. I bring deep expertise in GxP compliance, regulatory audits (USFDA, MHRA, WHO, TGA, etc.), QMS implementation, and laboratory operations. I’ve successfully led critical functions such as investigations, change control, deviation handling, CAPA, APQR review, and data integrity (DI) remediation.With hands-on involvement in commissioning of QC labs, validation of equipment, and facing multiple global audits, I ensure a perpetual state of compliance at every level. My leadership style focuses on empowerment, risk-based thinking, and driving a culture of quality across cross-functional teams.Key Competencies:QMS & Laboratory OversightRegulatory Audit ReadinessDeviation / OOS / CAPA Management21 CFR Part 11 & Annex 11 ComplianceSAP, LIMS, TrackWise, Chromeleon 7.2.10Quality Risk Management (QRM)Process & Cleaning ValidationTraining, SOP Simplification & People ReadinessRecognized as Performer of the Year at Cipla and multiple monthly awards, I am passionate about excellence and adding tangible value to organizations by enhancing compliance and quality standards. Let\'s connect to collaborate on opportunities in Quality Assurance, Compliance, and Pharma Operations.