Quality Assurance Deviations Specialist
Hybrid
RK5995
Contract 12 months
Dublin


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



The QA Specialist provides Quality Assurance oversight and subject matter expertise for deviations, investigations, CAPAs, and change controls. Working closely with Manufacturing, Engineering, Validation, Quality Control, and Supply Chain, the role ensures quality investigations are managed effectively and in compliance with GMP requirements, regulatory expectations, and Amgen standards.



Key Responsibilities:

• Provide QA oversight of deviations, investigations, CAPAs, and change controls, ensuring timely and compliant execution.
• Review and approve quality records, ensuring appropriate scope, root cause analysis, risk assessment, and corrective actions.
• Represent QA at Deviation Review Boards, Change Control Boards, and other cross-functional forums.
• Support complex investigations and provide quality guidance on compliance and operational issues.
• Monitor quality system trends and support continuous improvement initiatives.
• Contribute to Annual Product Reviews and quality metrics reporting, as required.
• Support internal audits, regulatory inspections, and inspection readiness activities.
• Perform all activities in compliance with Amgen safety standards and SOPs.
• Responsibilities may expand to include additional areas aligned with business needs.

• Bachelor’s degree in science, Engineering, Pharmacy, Biotechnology, or a related discipline.
• Minimum 5 years' experience in the pharmaceutical or biotechnology industry.
• Experience providing QA oversight of deviations, investigations, CAPAs, and change controls in a GMP environment.
• Strong understanding of GMP requirements, quality systems, and risk management principles.
• Strong analytical, problem-solving, communication, and stakeholder management skills.