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QP/QA Specialist

Job description

Do you strive for excellence in Quality? Are you a QP/QA? Would you like to join a team that makes a remarkable impact on people's lives? Then this might be the role for YOU!

You would be joining a highly focused research-driven biopharmaceutical company based in Co. Cork.

Job Responsibilities  

  • Contribute to the QA plan realization through participation in Quality and Process Improvement.
  • Implementation, maintenance, and development of QA systems.
  • Review GMP documentation SOP’s, validation protocols, and Exceptional Documents.
  • Write and review QA department procedures and reports as well as reviewing and approving other departmental procedures and reports.
  • Auditing and investigation.
  • Involvement in Internal Auditing when necessary, of FLI Departments as well as external auditing of Materials and Service Suppliers.
  • QP participates in change controls on site.
  • Assist in the preparation and review of QA department reports and metrics and report on key events and issues, etc.
  • Assist in New Product Introduction Activities when required.

Job Requirements

  • Level 8 in Chemistry or related Science discipline.
  • 4+ years experience in Quality.
  • Qualified person as defined in EU GMP Volume 4 and annex 26.
  • Experience of GMP auditing and documentation.

For a confidential discussion on this or any other current job opportunity please contact Meggan on 021 235 9144 / mtully@sigmar.ie

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