Vinit Pathak

Background

About Vinit Pathak

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 – 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.