Quality Assurance Specialist
| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3949 |
| Job Views | 4 |
- Description
Team Horizon is seeking a Quality Assurance Specialist on a hybrid basis on an initial 12-month contract.
This 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.
Why you should apply:
- This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
- Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
- 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.
What you need to apply:
- 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
