GDP Consultant and Director
GDP Pharma Consulting
Claire has worked within the pharma sector for the last 24 years. The first 15 years of her career were spent working in a variety of roles for a global manufacturer. These roles included Quality Manager for both manufacturing and non-manufacturing areas of the business and, latterly, as the site compliance auditor which involved undertaking regular audits of all areas related to the manufacturing and testing of respiratory and oral solid dose products. This included the introduction of new products fed through from the Research and Development arm of the business. She has significant experience in all areas of pharmaceutical manufacturing, particularly QMS implementation, Quality Assurance and project management .
Claire then spent 8 years at the MHRA as a GDP inspector and Operations Manager for GDP. The role involved inspecting the full portfolio of UK WDA(H) holders and respective business models, including challenging and non-compliant sites. She has an excellent understanding of how the EU GDP Guidelines should be applied to a companies operations and specialises in the development of appropriate QMS’s for businesses.
Claire now runs GDP Pharma Consulting with her business partner and fellow ex-MHRA inspector, Peter Coombs.
- Common Outsourced Activity and Transportation GDP Deficiencies
25 April 2023 11:30 am