Senior Supplier QA Specialist

  • Contract
  • Dublin

Website Ref:TPM04416

Summary:
A Senior Supplier QA Specialist is required for a biopharmaceutical company in West Dublin. The successful candidate will operate within the Supplier Quality team to support the qualification and post-qualification monitoring of GxP Suppliers. The incumbent will be a contributor in supporting the execution of the company’s plans and maintaining the company’s position as a knowledge leader in the biopharma industry.

Responsibilities:

  • Support the Global GxP Supplier approval and update processes.
  • Support the Supplier Change Notification (SCN) process to ensure Supplier changes are reviewed and assigned to the appropriate owners.
  • Support the Quality Agreement Management process.
  • Support process performance projects as directed.
  • Perform all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.

Qualifications & Experience:

  • B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry, Microbiology or other science.
  • Minimum of 7 years’ experience in Quality with medical device, pharmaceutical, or biologics experience.
  • This position requires the individual to understand and follow written SOPs, record all work legibly and in real time; close attention to detail is necessary.
  • A good understanding of the concepts and systems applied to cGMP operations.
  • The person will have experience with Technical Writing and Problem-Solving methods.
  • Working knowledge of computer programs (Microsoft Word, Excel, PowerPoint).

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.