An experienced quality professional with 40 years of experience in the pharmaceutical business, including 24 years Quality Assurance experience and 9 years as a validation manger/specialist, working in both R&D and production facilities.
Skills include:
- Auditing of a variety of suppliers & service providers, including CMOs, API,
excipients, primary and secondary packaging suppliers, testing laboratories & cell
bank manufacturers. - Experience of a range of product types, including gene therapies, monoclonal
antibodies, vaccines, therapeutic proteins, aseptic manufacture and powders for
oral use. - Validation of a range of facilities and equipment including process validation,
cleaning validation and analytical validation. - Design and implementation of quality systems for regulated products including Risk
Assessment, CAPA and Change Control processes. - QA management of supply chains.
- Hosting MHRA inspections
