Podcast Episode #8 - 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 all been in the United Kingdom and he is proud to be a British Citizen. Yogesh is also proud of his heritage and ancestorial 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 in science higher education and then a career in the biopharmaceutical industry.
The excellent training Yogesh received at David Begg Associates and the University of Strathclyde, for the qualification on 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 could arise via poor packaging and/or distribution controls that render a batch or part batch to become unsafe and/or ineffective.
Yogesh is passionate about ensuring that everyone involved in the manufacturing, quality control and supply chain understand the risks and they follow the correct procedures for ensuring protection and control of the product for its Quality, Safety and Efficacy requirements.
Yogesh promotes a very good understanding of Quality Risk Management by all staff involved in drug product manufacture and control. The key message being is 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 the USA & 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 ca 25 national and international audits of 3rd 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 H is registered as a “Qualified Person” under the Permanent Provisions of the EU Directives.