A QA Specialist is required for a biopharmaceutical company based in West Dublin. The successful candidate will support the Material Qualification processes including migration of site-based processes to the global process.
- Support the Material Qualification 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.
- Gather data and report quality metrics for internal processes and identify and implement improvement opportunities.
- Perform all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.
Qualifications & Experience:
- Relevant degree.
- Minimum of 4+ years’ experience in Quality with GMP pharmaceutical, or biologics experience.
- Experience in Material Qualification is a must.
- 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.
- Capable of identifying and mitigating risks.
- 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 firstname.lastname@example.org.