Overview
Quality Assurance Specialist Jobs in South Dublin, Ireland at PE Global
Title: Quality Assurance Specialist
Company: PE Global
Location: South Dublin, Ireland
The role:
PE Global is currently recruiting for a Continuous Improvement Specialist on behalf of a leading biotech company in Dublin South. This is an initial 12 month contract role.
Role Overview
The QA Specialist, Deviations 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.
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.
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
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to [email protected]
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
