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Profile of Tansey Millerick, B A Mod (Biochem)

Quality Management Systems and Regulatory Compliance Consultant

Tansey qualified with an honours degree in Biochemistry from Trinity College Dublin in 1975 and worked in the Clinical Diagnostics and Pharmaceutical industries in Ireland and in California. In 1987 Tansey started in consultancy and has progressed to become a Senior Quality and Regulatory Compliance Consultant with a strong client base in the Pharmaceutical, in-vitro Diagnostics, Medical Device and alied industries, offering services to clients in the design, training, implementation and maintenance of Quality Management Systems and operational procedures in compliance with US, EU and Irish regulatory requirements. She has also:

  • worked with client companies preparing for initial and follow up regulatory inspections by Irish, European or US regulatory agencies, or preparing for audits by potential customers or corporate company divisions
  • worked with the Irish Medicines Board in the documentation, training and implementation of Quality Management Systems and operational procedues in line with EMEA, EU, PIC/S, MRA and national statutory requirements
  • in line with the ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative, has developed a Process Mapping methodology, incorporating both Risk Management and Continuous Improvement initiatives, which are used to direct and facilitate client companies in understanding complex processes interacting within their sites, across national and international sites, and across US and European regulatory jurisdictions. Process Maps produced at material sourcing, manufacturing, testing and release and distribution levels, and describing activities for Market Compliance
  • at SOP level, has developed a methodology for SOP writing which approaches all procedures as processes, maximizes the use of flow charts, ensures no use of ambiguous text, ensures each step is made explicit and ‘risk critical� activities are examined and reduced, and clarifies areas of responsibility and shared responsibilities
  • provides the service of validating/re-validating a client's recall process, in compliance with regulatory requirements (mock recall)
  • provides the service of validating/re-validating a client's supply chain for regulatory compliance across possible multiple regulatory jurisdictions
  • as a trained Lead Auditor, provides an auditing service carrying out in-house mock Regulatory Compliance audits and auditing of 3rd party contract manufacturers, suppliers and service providers, e.g. distributors and logistics providers
  • works with client companies in the Pharmaceutical, Medical Devices, Food and Service industries to achieve ISO 9001 Quality Management Systems certification
  • works with Medical Device companies to achieve ISO 13485 certificatin
  • Tansey is also a trained Assessor of the Business Excellence Model (EFQM).

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