Diversified Clinical Quality Assurance Professional with a demonstrated history of auditing in the pharmaceutical industry in the areas of GCP, GCLP, Clinical Data Management, Biostatistics, Medical Writing, IVRS, Pharmacovigilance and Regulatory. Demonstrated success in coordination Pre-Approval Inspections (PAI), routine and directed Health Authority inspections. Lead and manage the implementation and maintenance of the Country Quality system across India, Srilanka, Nepal, Bhutan, and Maldives, embarking all concerned GxP country functions, ensuring safe, efficient, quality products, information and services are made available to meet patients and customers’ needs., Pharmaceutical