Michael Mccarthy Email & Phone Number

Current employer CCL Label Ireland which is focused on producing secondary packaging within cGMP nonsterile facilities. Responsible for establishing and continuously improving Quality Management system standards ISO9001 and PS9000, which covers the manufacture of packaging materials for medicinal products. Lead administrator for European QMS system, expanding into Asia & Canada in 2024. Experience in sustaining and support of the complaints management system, in problem solving by identifying and recommending solutions to problems encountered. Responsible for validation protocols preparation, employees training, conducting internal process and external audits, maintaining updated quality reports, quality SOPs and records, risk assessments (PUWER, general, COSHH). Oversee incoming and final inspection of product. Release of final batch documentation. Previous employer Icemos technology which is focused on producing Super Junction MOSFETs and Advanced Engineering Substrates within GMP quality system. Responsible for batch testing, final release, review and auditing of batch documentation. Destruction testing of both packing and on-line transistor fabrication samples. Inspection of facility ensuring quality, environment and production standards ISO 9001:2015, ISO14001:2015 and IATF 16949:2016 where maintained.Working previously as Quality Technician and Quality Assurance, responsible for batch release, including completion, auditing/review of batch documents for completeness and compliance to cGMP, internal requirements and regulatory dossiers submissions. In both positions I gained a lot experience in preparation and presentation of final reports that reflect audit's results and document process. I have experience in change control, gap analysis, preparation and amendments of standard operating procedures, competence packs and preparation of Quality Technical agreements.

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  Queen'S University Belfast

  Geography