QA Specialist
Location: Dublin, Ireland ( Onsite)
Contract Duration: 12 Months
We're looking for an experienced QA Specialist to ensure QC laboratory operations in a regulated biopharmaceutical environment meet cGMP, regulatory, and internal quality standards, while driving continuous improvement and supporting product integrity and patient safety.
Key Responsibilities
As a QA Specialist, you will lead and support QA review and approval activities across QC laboratory operations, including:
- Laboratory investigations, deviations, and associated corrective and preventive actions (CAPAs)
- Contract testing laboratory investigations and related documentation
- Operational SOPs, test methods, forms, and quality directives
- Annual Product Reviews (APRs) and trending reports
- Laboratory equipment and instrumentation qualification protocols and reports
- Method validation and technical transfer protocols and reports
- Change control documentation impacting QC activities
You will also:
- Establish and promote best practices and continuous improvement initiatives in partnership with Quality Systems and Compliance teams
- Ensure all QC activities comply with applicable policies, procedures, guidance documents, and global regulatory requirements
- Support QC laboratories during global regulatory authority inspections and market approval activities
- Contribute to the execution of the internal audit programme
- Support QC and QA Network Harmonisation initiatives across the organisation
Qualifications & Experience
- BSc in Science (or related discipline) with 3+ years' Quality experience in the biopharmaceutical/pharmaceutical industry
- Strong knowledge of cGMP laboratory compliance and equipment/instrument qualification
- Excellent communication skills with the ability to work independently and within cross-functional, matrixed teams
- Highly organised, adaptable, and capable of managing multiple priorities in fast-paced environments.
Apply now to be part of a Quality team committed to compliance, continuous improvement, and operational excellence.
