My Race in Life Sciences Series with Yogesh Krishan Davé

Yogesh’s career in pharma spans over 38 years, and he has operated his own UK-registered limited company for the past 12 years.

All his formal education has been in the United Kingdom, and he is proud to be a British citizen. Yogesh is also proud of his heritage and ancestral roots in India, and he has tried to integrate the best of both cultures.

Yogesh developed a passion for the natural sciences as a young teenager at a London middle school, when he was inspired by his chemistry and biology teachers. That led him on his journey through science higher education and then into a career in the biopharmaceutical industry.

The excellent training Yogesh received at David Begg Associates and the University of Strathclyde, for the qualification of eligibility as a Qualified Person (QP), taught him to understand the many risks associated with manufacturing that could lead to the making of a defective product, or defects that could arise via poor packaging and/or distribution controls that render a batch or part batch unsafe and/or ineffective.

Yogesh is passionate about ensuring that everyone involved in the manufacturing, quality control and supply chain understands the risks and follows the correct procedures for ensuring protection and control of the product for its quality, safety and efficacy requirements.

Yogesh promotes a good understanding of quality risk management among all staff involved in drug product manufacture and control. The key message is that there is poor or no chance of a patient knowing a product supplied is defective in any way, and even a small number of defective units can cause harm or even death.

Yogesh has lived and worked in the USA, Canada, UK, Switzerland and the Netherlands. He has a comprehensive understanding of USA and EU regulations, quality standards and the expected requirements for the manufacturing, testing and certification of both sterile and non-sterile medicinal products, including cell and gene therapy products.

Qualified as a lead GxP auditor, Yogesh has played key roles, including principal lead for hosting Regulatory Agency inspections for a number of companies. These inspections were highly successful for the company Yogesh represented.

To date, Yogesh has conducted around 25 national and international audits of third-party manufacturing organisations, quality control laboratories, API suppliers and a number of GCP inspections at clinical investigation sites.

Yogesh is a Chartered Chemist, a member of the Royal Society of Chemistry, a member of the Royal Pharmaceutical Society of Great Britain, a member of the Research Quality Association (MRQA), and is registered as a “Qualified Person” under the Permanent Provisions of the EU Directives.

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