Christopher Purt Email & Phone Number

Europe

Responsible for EU quality, operations including 3 manufacturing sites across Ireland and UK, supply chain and CMO management.

Anglesey

Plant Manager, named Responsible Person/ Wholesaler Dealer Qualified Person. Responsible for people, production, facilities, equipment and ensuring GMP and GDP compliance with MHRA and VMD site licences for manufacturing, release, storage and distribution of Human and Veterinary Pharmaceuticals and Healthcare Products for Bimeda UK.

Anglesey

•Provide QA support for EU importation of pharmaceutical products from third party Countries•Host Regulatory and Customer Audits •Manage/maintain the Site Master File & Site License•Management of the site QMS including oversight of GMP, change control, deviations, CAPA, calibration, validation, risk management, document control.•Manage QC of incoming goods and packing materials, packing line approvals, batch record review and status control of stock transfer on QAD system•Compilation of Product Quality Reviews (PQR's) on all licensed products packed at the site

St Asaph, Wales, Uk

Application of Lean; Defining the process. CTQ analysis. Activities, connections and flows.Development of purchase specifications and incoming QC processes.Development and writing of SOP, MBR, REC and SPE records from scratch.Electronic document control systems.Development and introduction of QMS. Management of deviations and CAPA.Troubleshooting technical issues through 6 sigma processes.Hands on approach in manufacturing and QC. Mentoring and training of current and new staff in QMS and procedural control.Validation of systems and process.Product transition from R&D to manufacturing.Professional use clinical trials.CE Marking.ISO 9001 and IS0 13485 surveillance and re-registration audit with notified body LRQA.Experience of Surface Mount Line Technology, Scienion ultraflow volume deposition, Diener plasma surface treatment, vision systems for QC and manufacturing processes, Fuji flow wrapper machine, ISO Class 7 clean room, ultra low humidity manufacturing, tracer gas leak detection methods.Commercialization of a novel MEMS sensor into a point of care device for blood clotting tendency.

Llanberis

Technical support for the manufacture and development of IVD kits and manufacturing processes through Lean, 6 Sigma and Design Control.

Cardiff, United Kingdom

Review and approval of device history records. Front line troubleshooting of technical product or process issues through 6 Sigma processes.

Cardiff, United Kingdom