QA Deviations Specialist

QA Deviations Specialist
Hybrid
RK5456
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.




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 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.
• Ability to work independently and effectively in a cross-functional environment.
• Excellent organisational, communication, coordination, and meeting facilitation skills.
• Proven track record of supporting continuous improvement initiatives within a regulated environment