Nirav T.

Quality and Compliance Leader

Role
Clinical Operations Qa Manager at Novartis
Location
Edison, NJ, US
LinkedIn followers
500 followers

About Nirav T.

I have experience in a quality and/or compliance environment in a highly regulated GxP (GMP and GCP)regulated pharmaceutical industry. In addition I have the experience with the following Quality Systems: CAPA and, Document and Records Management, Complaints Management, Change Control, Validation of products and processes, Product Release and GxP/Compliance Training. I have full understanding of GAMP 5. I have strong documentation, analytical, and technical writing skills and a thorough understanding of FDA requirements and guidance. Recent experience has brought additional development of my skills in high throughput data entry and transactional systems, where first-time-right quality is paramount for regulatory compliance.

Experience

  1. Clinical Operations Qa Manager

    Novartis

    Jan 2018 — Present · East Hanover, NJ, US

Education

  • Rutgers University

    Bachelor of Science, Nutritional Science

    2005 — 2010

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Nirav T. — Clinical Operations Qa Manager at Novartis in Edison, NJ, US | Unifers