Michael T. Email & Phone Number

Crewe, England, United Kingdom

Development and maintenance of Quality Systems (e.g. ISO 9001) related to quality manufacturing and supply of reflective materials, reflective tapes and films for end applications such as high visibility garments, Fire Fighters uniforms and fire retardant overalls.

Stoke-On-Trent, England, United Kingdom

Responsible for maintaining GMP compliant Pharmaceutical Quality System (PQS). Coordinating, performing and hosting Regulatory Inspections (MHRA/FDA) and Internal/External Quality Audits; Hosted successful FDA and MHRA Inspections in Sep 2019 and Jun 2020 respectively. Continuous Improvement and development of all aspects of the PQS including OOS, Deviations and CAPA.

Nantwich, England, United Kingdom

Freelance consultancy service to the Pharmaceutical industry providing quality, technical and manufacturing support related to production and quality assurance operations including internal external audits in compliance with cGMP.

Speke, Liverpool

Provision of Technical Services and Manufactuing Support for ELANCO products including validation of manufacturing processes, investigation of deviations/OOS results leading to process improvements. Provision of on-site quality and technical support to several EU Contract Manufacturers of Elanco veterinary medicines (Steriles, liquids and dry powders).

Wrexham, Wales, United Kingdom

• Lead Pharmaceutical Supplier Auditor, IRCA Qualified (ISO 9001:2001/GMP) • Management and training,of Change Control, Unplanned Events (deviations), CAPA (Trackwise).• Risk-based (ICHQ9, FMEA) evaluation of GxP rated suppliers for prioritisation of audit schedule. • Investigation of quality related supplier issues/customer complaints.• Training of quality staff and support to iSAP/Quality interface as iSAP Key User, Quality.• Author/Quality Approver of SOPs, Technical Reports and GMP documents.• Self-inspection (Internal GMP audits).• QA approval of URS, IQ, OQ and PQ validation protocols/reports related to the design and build of new Quality Control Laboratory testing facility. • Quality Projects manager for priority site projects (e.g. introduction of new sporicidal biocide).

- Revised and updated Global Manufacturing Guides for metered dose inhaler respiratory products for secondary manufacturing sites in Europe. Coordinated product knowledge transfer from UK donor site to EU recipient sites (Based in Evreux, France).- Provision of technical support regarding product transfer, process validation, process improvement and routine manufacturing investigations within the Respiratory Technology Cell. Responsible for maintaining functional standards and delivery of technical projects within agreed timescales. Author of technical reports, experimental trial protocols and process related validation protocols. Responsible for self-inspection audits and departmental standard operating procedures (Based in Speke, Liverpool). - Introduction of new products from both donor and R&D sites. Responsible for project management, process development and technical support within the syringe, ampoules and vials production facilities of the Steriles Product Stream (Based in Barnard Castle, Co Durham). - Technical support for UK inter-site product transfers. Responsible for OQ and PQ validation of new processes and new equipment associated with the manufacture and packaging of topical creams and oral liquids. Supervision of production operators and packaging staff (Based at Dartford, Kent). - Quality assurance Supervisor, in-process QA of tablet manufacture, aseptic aerosol production and the filling/final packaging of topical and oral liquids. Responsibilities also included investigation of customer complaints, customer returns and approval of packaging specifications (Based at Crewe Hall, Cheshire). - Senior Microbiologist, hygiene/environmental monitoring of manufacturing and filling/packaging areas, validation of microbiological methods, training and supervision of laboratory staff. QA Safety Officer responsible for on-site safety audits (Based at Crewe Hall,Cheshire).

Hnc Applied Biology, Microbilogy And Biochemistry, Pass

Onc Medical Laboratory Sciences, Medical Microbiology And Bacteriology, Merit

Education record