
Tim is a leader within pharmaceutical Quality Assurance (QA) with over 25 years experience in Operational and Corporate positions gained in both large and small companies. With a PhD in microbial biochemistry from University College Cardiff, Tim is also a Chartered Chemist, a member of the Royal Society of Chemistry, the British Association of Research Quality Assurance (BARQA) and the Pharmaceutical Quality Group (PQG).
Tim has in depth knowledge of API manufacture, primary and secondary product manufacturing (all dosage formats). He also has first hand experience of the drug development functions, including the manufacture and control of investigational medicinal products for use in clinical trials.
Tim is experienced in all GxP systems and regulatory requirements within Europe, USA and Asia has a wide range of skills including:
- Development, maintenance and continuous improvement of quality management systems
- Management of in-house and third party manufacturing quality assurance groups
- Hosting successful regulatory authority inspections (FDA and MHRA) in support of manufacturing and marketing authorisations
- Management and auditing of supply chain (goods inwards to distribution of product)
- Quality management of validation systems
- Design and commissioning of manufacturing and laboratory facilities
- Analysis of starting materials and products
- Troubleshooting



