Manan Dave

Associate Director (head - Validation & Engineering Qa) at Kemwell Biopharma

Manan Dave has a diverse work experience in the pharmaceutical industry. Manan has worked in various roles related to validation, engineering QA, and quality assurance.

From 2019 to present, Manan has been working as a Senior Manager (Head - Validation & Engineering QA) at Kemwell Biopharma. In this role, they oversee the validation life cycle of process, equipment, utilities, laboratory equipment, and computerized systems. Manan also leads and manages projects for commissioning, qualification, and software system upgrades.

Prior to this, from 2015 to 2019, Manan worked at Dr. Reddy's Laboratories. Initially, they held the position of Manager, where they focused on equipment and system commissioning, qualification, and computer system validations. Manan then progressed to the role of Assistant Manager, where they specialized in biopharmaceutical validations and plant engineering.

Before joining Dr. Reddy's Laboratories, Manan worked at Mylan Laboratories Limited from 2013 to 2015 as an Assistant Manager. In this role, they primarily focused on quality compliance and management systems, including investigations, deviations, change controls, audits, and complaints.

From 2011 to 2013, Manan worked at Biocon Limited as a Senior Executive in Quality Assurance. Here, they were responsible for facility and equipment qualification, ensuring cGMP environment, coordinating microbiological qualification, and managing pharmaceutical water systems.

To start their career, Manan worked as a Management Trainee in Production at Sharp Menthol India Limited from July 2011 to November 2011.

Overall, Manan Dave's work experience spans across various aspects of validation, engineering QA, and quality assurance in the pharmaceutical industry.

Manan Dave completed a Master of Technology degree in Pharmaceutical Operations & Management from Birla Institute of Technology and Science, Pilani from 2016 to 2018. Prior to that, they earned a Master of Technology degree in Chemical Engineering from Malaviya National Institute of Technology Jaipur from 2009 to 2011. Manan also holds a Bachelor of Technology degree in Biotechnology from Amity University, Greater Noida Campus from 2005 to 2009. Additionally, Manan obtained a certification in Quality Management Systems from Amity University - British Standard Institutions in 2008. Before pursuing higher education, they completed their HSC (High School Certificate) in PCMB (Physics, Chemistry, Mathematics, Biology) from K. C. College, Mumbai from 2003 to 2005.

Links

Previous companies

Dr. Reddy's Laboratories logo
Biocon logo

Timeline

  • Associate Director (head - Validation & Engineering Qa)

    April 1, 2024 - present

  • Senior Manager (head - Validation & Engineering Qa)

    June, 2023

  • Senior Manager (lead - Validation & Engineering Qa)

    October, 2021

  • QA Engineering Manager

    June, 2019