Christopher Purt

Experience

• 

  Ortho Clinical Diagnostics

  Sept 2000 - Sept 2002

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

  • QA Release officer

    Sept 2001 - Sept 2002

  • Technical Specialist

    Sept 2000 - Sept 2001
• 

  Siemens Healthcare

  Sept 2002 - Jun 2012

  Technical Operations Scientist

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

• 

  Microvisk

  Jun 2012 - May 2015

  Quality Engineer

  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. Show less

• 

  Bimeda

  Apr 2015 - now

  •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 Show less

  • Bimeda Operations Manager Europe

    Jun 2022 - now

  • Plant Manager/ Responsible Person/ Wholesaler Dealer Qualified Person

    Mar 2017 - Jun 2022

  • QA Manager

    Apr 2015 - Mar 2017