Quality Assurance Specialist

1 month ago


Cardiff, Cardiff, United Kingdom Ipsen Biopharm Ltd Full time

We are seeking a Quality Assurance Specialist to join our QA Operations Team at Ipsen Biopharm Ltd. This permanent position is located at our Wrexham site in North Wales and will report directly to the QA Process Leader.

The successful applicant will have sound knowledge of cGMP and QRM relating to aseptic manufacturing and will be organised with a good sense of prioritisation, time and risk management techniques.

Key responsibilities include:

  • Review and approval of batch documentation to support the QPs in certification of site manufactured batches and release in accordance with EU regulatory requirements.
  • Providing Quality Oversight across manufacturing streams utilising knowledge of cGMP regulatory guidelines, and industry standards.
  • Participating in Quality Management Processes: Unplanned Events, Complaints, Corrective/Preventive Actions (CAPA), Change Control, Product Recall, Blue Mountain, SAP and other site systems as required.

Requirements:

  • A levels/equivalent, including a science subject or evidence of science-based education/training.
  • 3+ years pharmaceutical experience in sterile manufacturing of which more than 1 year in Quality Assurance.
  • 1+ year in pharmaceutical manufacturing in a Quality role.


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