Vikrant Sharda

Background

About Vikrant Sharda

High impact Quality professional with extensive experience in the Pharmaceutical and Healthcare sectors, possessing a robust background that showcases a commitment to excellence in Quality & Compliance. My diverse expertise encompasses various areas of drug formulation, including, Active Pharmaceutical Ingredients (APIs), Oral Solid Dosages, Oral Liquids, Ointments & Creams, Aseptic Formulations (Ophthalmic and Injections), Topical Liquids, FMCG & Medical Devices. Skilled in handling various regulatory inspections - USFDA, MHRA, MCC, EUGMP, WHO, MOH - Russia, Ukraine, ISO, CE marking, NABL etc. Certified lead auditor - ISO 9001. Perform audits - Vendor Development and Qualification, Cross Audits, For-Cause audits, Data Integrity (DI) etc. Expert in implementing Data integrity Controls in the Laboratory and in the Manufacturing, areas including utilities. Leading Compliance at Johnson & Johnson as Sr. Manager Regulatory Compliance - APAC for India, China and Japan sites as part of JJRC (Johnson and Johnson Regulatory Compliance) Quality & compliance Team. Responsible for Independent Internal Audits, External Audits - Health Authorities and Notified Bodies Inspections - Preparations, Hosting and Responses. Ensuring the Health Authorities commitments and CAPA actions are implemented in full. Independent investigator for OSI (Office of special Investigations). Prior roles at Reckitt further underscore contributions to Regional Quality Assurance and External Manufacturing excellence in South Asia. Skilled in supplier management, technology transfer, and harmonization of quality systems, the work consistently supports organizational goals. With a mission to drive quality and compliance in healthcare, the approach combines deep technical knowledge with a commitment to operational integrity and collaboration. I began my career as a QC Chemist and evolved into a Subject Matter Expert (SME) for chromatographic techniques, calibrations, analyst qualifications, analytical test method validations and data integrity controls. As a participant in the Talent Enhancement Program (Samurai), I gained valuable knowledge in several critical areas, including, Change Controls, Deviations, Qualification and Validations, Self-Inspections, Management Reviews, Risk Management, CAPA, Lean Labs, Budgets etc, with successful completion in 2011, I transitioned as Site Quality manager, where I further developed my skills across various elements of Quality Management Systems (QMS). This experience has significantly contributed to my professional growth and expertise in the field.