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Quality Assurance Specialist

2 weeks ago

Ballydine Cross Roads, County Tipperary, Ireland Merck Gruppe - MSD Sharp & Dohme Full time

At Merck Gruppe - MSD Sharp & Dohme, we are committed to 'Inventing for Life' in all that we do. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes.

Your key responsibilities will include:

  • Reviewing and approving production and analytical documentation to ensure conformance to GMP and regulatory requirements.
  • Performing and reviewing complaints and deviation investigations, change controls and CAPA's.
  • Creating and maintaining assigned SOPs.
  • Compiling data for reports and presentations, providing data interpretation and drawing conclusions.
  • Completing audits to ensure compliance to SOPs, GMPs and applicable regulations.

You will also have the opportunity to:

  • Support product recalls and stock recoveries as appropriate.
  • Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.
  • Identify compliance gaps and make recommendations for continuous improvement.
  • Assist in the induction process for new starters and training of other staff.

We are looking for someone with a degree in a Science or Engineering discipline plus some industrial experience, or considerable industrial experience. Knowledge and demonstrated expertise in Lean / Continuous Improvement is also required. Experience and knowledge of GMP Requirements for Electronic/paper-free operations is highly desirable.