A Pharmaceutical Professional, having more than 18 years diversified experience in Pharma Sector. Part of Strategic Leadership team, achieved major milestones based on Product quality and audit compliance. Leading Quality Operations right from development cycle till deliverance of targeted volumes in accordance with GMP standards to ensure consistent quality production by developing and enforcing Good Manufacturing Practices (GMP), Quality Management System (QMS), Process Optimization, Productivity enhancement and Operational Excellence. A Certified Lead Auditor of ISO Integrated Systems with an exposure of more than 500 audits of Pharmaceutical Manufacturing Sites, Raw & Packaging Materials Vendors/ Suppliers, Calibration Agencies, Contract Laboratories, Distributors and Service Agencies. A highly motivated person having strength to excel in conveying complex ideas clearly and persuasively, deeply enthusiastic and committed to contributing to the success of team and company. A Self Motivator with High Energy, Passionate, Confident, Results Oriented, Solution Focused, Critical Thinking capabilities and Compliance to Norms & Discipline. I am looking to target a leading position in the pharmaceutical industry, where I may flourish organizational dynamics to another level by applying my utmost experience, knowledge and skills. Also lead Vendor Qualification Program right from sourcing, budgeting, auditing, testing, trial/ scale-up batch manufacturing, Stability & commercialization. Expert in handling and management of all QMS functions including Out of Specification, Out of Trend (OOS/ OOT), Deviation, Change Control, Investigation, CAPA, Product Quality Review, Internal Audit, Quality Risk Management System, Batch Record auditing and market release, GMP and Scientific Trainings, Management Review, etc. Have gone through several International audits/ inspections/ accreditations successfully which include WHO Prequalification, PIC/S (Pharmaceutical Inspection Co-operation Scheme) Inspection and about 25 countries Regulatory agencies Inspections.