Head of Quality for Commercial and Clinical Operations, responsible for client quality management with clients in the UK, EU and USA. Hosted client audits (approx. 25+ per year), also focused on CMO site and supplier audits in the EU and US. Host for regulatory audits including MHRA, US FDA and Turkish inspectorate as well as communication with other authorities. Management of Quality support for both internal departments and clients. Active QP across multiple dosage forms including solid dosage, powders, aseptic and terminally sterilised products, for both licenced commercial and investigational stages of products.

Management of all Commercial aspects of Quality support both internally and externally for a large number of clientsSupport for QMS systems. Review and assessment of Validation packages including QMS as well as equipment and facilities. Provision of topic specific training including GMP, Documentation, Deviations, Role of the QP etc. Monitoring Key Performance Indicators such as Right First Time and On Time in Full to ensure improvements.

Focused on Quality support for Sterile manufacturing Operations, inc. the Cytotoxic facility

Quality Manager, Clinical Pharmacy Research ServicesPreviously Senior Quality Manager / Quality Manager, Therapeutic division (commercial products)Active QP for commercial products (Biological Steriles) and Clinical Trials materials; including ATMPs

Qualified Person - inc. New product introductionPreviously QA Team Leader

Part of Graduate Training programme: Quality Officer / Production Supervisor / Purchasing Team member / Technical Officer...Company originally named Unipack, then PCI then Cardinal Health; a contract assembly company working with many of the UK's blue chip Pharma companies.