An accomplished Senior Quality and Regulatory professional with overall 10+ years of progressive experience in Clinical trials, QA/QC, Regulatory, Medical devices and process excellence. Prior to Techsol Life Sciences, I worked with Hinge Clinica, MakroCare and GVK Biosciences. I have extensive experience in establishing Quality Management systems as per the ISO9001, ISO27001, ISO14155, ISO13485 and applicable national and international standards. Actively contributed in facilitation of various Clinical audits and Sponsor Audits i.e. USFDA, WHO, DCGI and EMA and clients like Cipla, Zydus, MERK Serono, Roche, Abbott, Dr. Reddy’s Labs, Healthium, AVS Santen, Unison Pharma, Leiutis, Aizant, Biophore and etc.CORE COMPETENCIES:• Quality Planning & Management • Compliance Harmonization• Process Management• Client Management• Process Control & Verification • Risk Management • Compliance to Quality standards• Audit Management