QA Specialist (Material Qualification)

Summary:
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.

Responsibilities:

• 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.