A passionate Clinical & Pharmaceutical Research professional to seek a career in Clinical & Pharma Research and Development organizations and utilize my knowledge, experience of Clinical Trial, Pharma R&D, Quality Assurance, Audits & Inspections, Pharmacovigilance (Pv), Clinical Data Management (CDM), Medical Writing (MW), Regulatory Affairs (RA), Training & Compliance, Risk & Compliance, Validation domains in the organization to help me grow in my career aspirations.Overall, 20 years of working experience in Clinical Trial & Pharma R&D (Quality Assurance & Compliance,Audits & Inspection Management, SOP & Trainings Management, Pharmacovigilance, Regulatory Affairs, Computer System Validation, Clinical Data Management, Central Reference Laboratory and as Lecturer). • Handled complete QA and Quality Management System (QMS) implementation, setup, and execution for clinical trials, performed end to end QA activities as individual contributor, including supervision & management of teams. Participated in US FDA Inspections, ISO, NIH, CAP, NABL, CQA, Client and 3rd Party Vendor audits. • Skilled to develop & implement Training Management System including taking trainings.• SOP Management including writing of Quality Manuals, SOPs, OPIs, Instruction Manuals in Quality as well as various other teams.• Skilled to do Computer System Validation (CSV) with expertise & specific knowledge of CSV methodologies, principles for variety of Pharma tools and applications.• Experience in conducting feasibility visit and audits for Phase II – III Clinical trials, Bio Availability & Bio Equivalence sites and internal audits within the organization I worked for. Further supported regulatory inspection, client & third-party client/vendor audits. Good knowledge of regulatory guidelines, GCP, GLP and GCLP. Also conducted training on Inspection & Audit management, SOPs, GCP, GLP and GCLP including mock interviews. • Certified Management Framework (MF) and Internal Auditor (IA) in my current organization to conduct audits for Life Science (LS) Domains and Accounts.• Additionally, worked as a lecturer teaching “Clinical Research” since 2002 to 2005 (3yrs) at Padmashree D. Y. Patil College of engineering, Pune (for M. Tech Biotechnology and M.Sc. Biotechnology).Expertise in: QA & QMS, Compliance, Audit & Inspection Management, Training - Learning & Development.