Quality Assurance Deviations Specialist

Life Science Recruitment; Leinster; On-site; EUR 75,000 - 125,000; Full time

Job summary

Life Science Recruitment is assisting an award-winning pharmaceutical organisation based in Dublin to recruit a QA professional. The role provides QA oversight of deviations, investigations, CAPAs and change controls, ensuring timely and compliant execution.

You will review quality records, represent QA at Deviation Review Boards and Change Control Boards, support complex investigations and monitor quality system trends to drive continuous improvement and regulatory readiness.

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology or 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.
• Excellent organisational and stakeholder management skills.

Responsibilities

• Provide QA oversight of deviations, investigations, CAPAs and change controls, ensuring timely and compliant execution.
• Review and approve quality records with 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 activities in compliance with safety standards and SOPs.
• Responsibilities may expand to include additional areas aligned with business needs.

Skills

QA oversight

GMP knowledge

Audit/inspection readiness

Stakeholder management

Cross-functional collaboration

Analytical thinking

Education

Bachelor's degree in Science/Engineering/Pharmacy/Biotechnology or related

Job description

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.

Education and Experience:

• 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