Abhijit S. Kulkarni

About Abhijit S. Kulkarni

Seasoned Quality professional offering around 29 years of enriching experience, having worked in leadership roles with reputed pharmaceutical companies covering multiple dosage forms, products, technologies and functions. I am presently working as \"Vice President-Corporate Quality Assurance\" at \"Lupin Ltd, Mumbai, India\".For my outstanding contributions in implementing improved quality processes and demonstrated efficiencies in steering Quality Operations across wide span covering new and mature sites, regional operations, external / contract manufacturing and commercial operations, I have been awarded the citation of “50 Most Talented Quality Professionals of India” across all manufacturing & service industries in India in 2014 by \"World Quality Congress\". As a senior professional, I am deft in looking after the Corporate Governance processes like Monitoring of Business Competences, Risk Management, Legal & Regulatory Compliance, Issue/ Crisis Management and Due Diligence. I have served as a Certified Auditor and a Trainer, having proven competencies in Auditing and Capacity Building, Strategy Deployment. I have handled audits from multiple agencies like Indian FDA, WHO, MHRA, FDA, AFSAPPAS etc. I am well conversant with Six Sigma & Operational Excellence principles & their applications. Have proven achievements in commissioning & qualification of new sites & putting them in operation. I have trained many professionals on Qualifications & Validations and Quality Management Systems.

Experience

1. VP Cqa (Global Compliance & Biotech Cqa)

   Lupin

   Oct 2021 — Present · Mumbai, IN

Education

• Goa University

  M. Pharm, Quality Assurance

• Shivaji University

  Bachelor of Pharmacy, Pharmacy

Skills

• Analytical Chemistry
• Verification and Validation (V&V)
• Gxp
• Quality Auditing
• Change Control
• Management
• 21 Cfr Part 11
• Glp
• Team Management
• Regulatory Affairs
• Cross-Functional Team Leadership
• Cleaning Validation
• Quality Assurance
• V
• Quality Control
• Gmp
• Regulatory Submissions
• Quality Management
• Business Development
• Pharmaceutical Industry
• Sop
• Fda
• Pharmaceutics
• Drug Discovery
• Quality System
• V&V
• Document Management
• Formulation
• Good Laboratory Practice (Glp)
• Performance Management
• Capa
• Validation
• U.s. Food and Drug Administration (Fda)
• Regulatory Requirements
• Standard Operating Procedure (Sop)
• Technology Transfer