QA Specialist

  • Contract
  • Dublin

Website TPM04773

Summary:
A QA Specialist is required for a biopharmaceutical company in West Dublin.

Responsibilities:

  • Support the global supplier and material approval processes including migration of site-based processes to the global process.
  • Support management of Quality Agreements.
  • Support Supplier Change Notification process to ensure appropriate change control and regulatory updates have been made prior to making changes.
  • Support monitoring of approved Suppliers through data gathering and reporting.
  • Support periodic review of approved Suppliers.
  • Gather data and report quality metrics for internal processes and identify and implement improvement opportunities.
  • Support Continuous Improvement of the Supplier Quality System.
  • Support audits and inspections, as appropriate.
  • Perform all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.

Qualifications & Experience:

  • B.Sc. or equivalent in Biological Sciences, Chemistry, Microbiology or other science.
  • Minimum of 4+ years’ experience in Quality with medical device, pharmaceutical, or biologics experience.
  • Experience in Supplier Quality, Material Qualification, Procurement, Quality Assurance, or Auditing.
  • Experience with Quality Risk Management and Structured Problem-Solving tools.
  • A strong customer focus and ability to prioritize and adapt to business needs.
  • Knowledge of applicable international GXP regulations and standards.
  • Strong business partner with a focus on delivering results.
  • Excellent written and verbal communication skills.
  • Experience with high performance teams, cross functional projects.
  • Experience with Technical Writing.
  • Experience working with mature supplier quality system.
  • Previous global Quality System development/deployment experience.
  • Experience supporting regulatory inspections.

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