We are working with a large healthcare company who are looking for a QA Microbiology Specialist to support their Quality Assurance Team.
In this role, you will be responsible for:
Ensuring periodic quality review of Environmental Monitoring results. Tracking and Reporting of Quality Metrics on Environmental Monitoring for Internal and external use. Qualifying, Auditing and monitoring the service level of external laboratories. Regularly reviewing the site compliance versus company guidances- planning and implementing guidance. Implementing tailored Sterility Assurance programmes according to company guidelines. Supporting the local implementation of Sterility Assurance Programmes. Tracking and reporting quality metrics for the Sterility Assurance Programme for local implementation. Provide support and lead investigations for product and process deviations. Providing support to validation activities. Preparation, review, approval and distribution of controlled documents.
BSc in Science with experience in industrial microbiology Excellent knowledge of EU GMP regulations Have experience in the use of quality improvement and problem solving tools (F.M.E.A., Capability Studies, Process Mapping, DMAIC, PDCA, etc…), and the interpretation of data Certified training as Lead or Internal auditor and aseptic experience is desirable
For more information on this role, or to apply, please contact Saoirse on or