Mike Breese

Senior Quality Consultant (QP)

Mike is an established QA professional with Qualified Person status and extensive experience in the Life Sciences Industry. An interim QP/Auditor for Fisher who has consulted for more than 20 years.

Skills include:

  • Quality Assurance in Biotechnology, Pharmaceuticals, Device Development and associated sectors
  • Corporate compliance audits as Lead Auditor and support. Management and quality auditing of sub-contractors and suppliers of API (chemical and BioTech), Clinical Material, Raw Materials, Device Components and Assembly, Packaging, Distribution and finished product. GMP, GDP, GLP and GCP auditing.
  • Training and presentations in a wide range of topics relevant to the Pharmaceutical industry.
  • QP review and release of Therapeutic and Clinical Trial products specializing in Biotechnology and Vaccines.
  • Quality Assurance Management providing short or long term cover for a wide range of Pharmaceutical product categories including Research and Development, Clinical Trials, Technical Transfer, Primary and Secondary manufacturing of sterile and non-sterile products.
  • Preparation for, and management of, Regulatory inspections.
  • Development, construction and implementation of Quality Management Systems in European and International offices and facilities.
  • Writing, formatting and implementing policies, guidelines and procedures across multi-national companies. Facilitating process development and introduction.
Mike Breese
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contactus@greyrigge.com