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.
