GMP QA Specialist: Deviations, CAPAs & Change Control

Ascend Project Management; Dublin; Hybrid; EUR 60,000 - 80,000; Full time

Job summary

AscendPM is recruiting on behalf of a leading global biopharmaceutical organisation for a Quality Assurance Specialist to join its team in South Dublin. The QA Specialist will provide quality oversight and subject matter expertise across deviations, investigations, CAPAs, and change controls, working closely with Manufacturing, Engineering, Validation, Quality Control, and Supply Chain.

You will help ensure investigations are completed on time and meet GMP, regulatory, and site requirements.

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, or a related discipline.
• Minimum of five 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, pharmaceutical quality systems, and quality risk management.
• Strong analytical and problem-solving skills, with the ability to work independently and across functions.
• Excellent communication, organisational, stakeholder management, and meeting facilitation skills.
• Proven track record of supporting continuous improvement in a regulated environment.

Responsibilities

• Provide QA oversight of deviations, investigations, CAPAs, and change controls, ensuring timely and compliant completion.
• Review and approve quality records, assessing investigation scope, root cause analysis, risk assessments, and the suitability of corrective and preventive actions.
• Support complex investigations and provide QA guidance on compliance and operational issues.
• Represent QA at Deviation Review Boards, Change Control Boards, and other cross-functional meetings.
• Monitor quality system trends, support continuous improvement initiatives, and contribute to Annual Product Reviews and quality metrics reporting.
• Support internal audits, regulatory inspections, and inspection readiness activities.
• Follow site safety standards and SOPs, and support additional QA activities as business needs evolve.

Skills

GMP knowledge

Quality systems

Investigations

Analytical skills

Cross-functional collab

Education

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

Tools

LIMS

Job description

AscendPM is recruiting on behalf of a leading global biopharmaceutical organisation for a Quality Assurance Specialist to join its team in South Dublin. The QA Specialist will provide quality oversight and subject matter expertise across deviations, investigations, CAPAs, and change controls, working closely with Manufacturing, Engineering, Validation, Quality Control, and Supply Chain.

You will help ensure investigations are completed on time and meet GMP, regulatory, and site requirements.