A member of the Chartered Quality Institute and holding Chartered Quality Professional status, the management positions I have held over the last few years have enabled me to extensively develop my understanding of quality management systems and regulatory requirements.
Supporting the supply chain in all aspects of customer and supplier interface, chairing technical meetings globally, all aspects of GxP / QA systems including CAPA & change management, ISO certifications, supplier assessment / audit and approval, distributor management, complaints management, internal audit, document management and implementing quality training where necessary. I also have a good understanding in regulatory submission work.
I am an engineer by trade and have extensive experience in the manufacturing, packaging and assembly line processes; this includes all aspects of validation activities OQ, PQ and IQ. I have been an auditor for the past 17 years and have audit experience that includes all aspects of supplier management worldwide, with a large part of that time spent in the manufacture of medical devices, utilising standards such as ISO13485 & QSR 21 CFR part 820
Specialities: Auditing (Internal / External) ISO13485:2016 Certification, Budgeting, Business Planning, Quality Systems, SOP's, Training, Continuous Improvement, CAPA, Customer Relations, Document Management, GxP, Policy Analysis, Project Management, Supply Chain Management, Validation, Medical Devices, Pharmaceutical, Risk Management. ISO 13485. Distributor Management. Regional & onsite manufacturing.