Vishal Mahale

About Vishal Mahale

We are what we repeatedly do. Excellence, then, is not an act, but a habit. – Aristotle…

Experience

1. Assistant Manager Quality Assurance

   Johnson & Johnson MedTech

   Apr 2015 — Present · Aurangabad, IN

   More than 22 years of diversified experience in pharmaceutical, Medical Devices industries handling Drug Products, Drug Substances, Medical devices and combination products in various fields like Quality assurance, Quality Control, Analytical R&D, Synthetic R&D etc.Expertise in master data configuration management and deployment of Laboratory Information Management Software (LIMS). Well versed with Software Development Life-Cycle (SDLC) process.Responsible for ETHICON product Information Database in SAP system.Responsible for smooth functioning and software lifecycle management with 21 CFR compliance requirements.SME for Lifecycle management for Laboratory Equipment, Analytical Test Methods, Change Control Process, concurrent process validations, Retrospective validation like Product Quality Review (PQR), Non-conformance/ CAPA process etc.Moved as Senior Executive and promoted to Assistant Manager in Medical Devices ETHICON, Aurangabad from Senior Scientist, Analytical R&D of drug products/ APIs, International Technical Centre (ITC), Johnson & Johnson Limited, L.B.S. Marg, Mulund, Mumbai.

Education

• Pune University

  Master of Science (M.Sc.), Organic Chemistry

  1997 — 1999

• Pune University, Pune

  Bachelor of Science (B. Sc), Chemistry

  1996

Skills

• R&D
• Gmp
• Capa
• Biotechnology
• V&V
• Cleaning Validation
• Lims
• Quality Assurance
• Gas Chromatography
• Good Laboratory Practice (Glp)
• Sop
• Quality System
• Technology Transfer
• Quality Control
• Fda
• Glp
• Chromatography
• Pharmaceutical Industry
• Dissolution
• Regulatory Affairs
• Hplc
• Validation
• Analytical Chemistry