Profile: Over 12 years of Total Quality Management experience working in Life-Sciences, Clinical research, Pharmacovigilance, Data management, Data Validation, Data Science, Technology, Bioinformatics, and Regulatory domain. Supported Total Project Quality management (KPI, Training and compliance), Process development and Process optimization, Data Management, Clinical Trials. Assisted over 150 GCP/GVP inspection (USFDA, UK MHRA, EMEA, CDSCO). Audited over 80 clinical trials, pharmacovigilance, and Data management domains. Certified Auditor/Lead Auditor ISO 9001:2015 Quality Management Systems & ISO 19011:2018 Guidelines on Audit management Systems TUV SUD ISO/IEC 27001 Information Security Management System Skill front. Preferred countries: Global auditing services. Business language: English. Based in Pune.