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