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Organisational Structure Biotechnology Sector

Depending on the size and complexity of the Biotech company, there can be a mixture of the following Departments

  • Validation -Validates process, and equipment so that they are functional and in-line with business and regulatory requirements.
  • Research & Development (R&D):takes various forms, researching ideal formulations of drugs, researches improved analytical techniques or changes processes to optimise yield of product.
  • Process / Production -ensuring the Biotech process runs as it should, handling deviations and constantly monitoring conditions to ensure optimum yield of the product. Involved in all stages from upstream to downstream processing and purification.
  • Regulatory Affairs- management of the preparation and submission of regulatory documentation to the relevant government regulatory bodies - IMB, FDA etc. Maintenance of existing molecule applications and dossiers.
  • Quality Assurance(QA)- responsible for the development and management of quality systems within the department . The Qualified Person signs off on the batch (if it's a finished product facility), all associated documentation must be prepared by the QA Dept.
  • Quality Control(QC)- check incoming, in process and outgoing product quality using analytical techniques in the laboratory. Produce documentation for QA to support the batch release.
  • Supporting Functions- depending on the company and their level of involvement in Ireland, other functions can range from HR to Supply Chain, Technical Services, Finance and Biotechnology. These supporting areas have been subject to a recent upturn recently, as companies are looking to consolidate and re-organise their business in various ways.