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Job Reference #
4321
Other
Dublin
Permanent
Salary not disclosed
Published on:
10 Sept 2026
Quality Assurance Specialist
Role: Senior Quality Assurance and Compliance Specialist
Reporting to: Head of Quality Assurance and Compliance
Role and responsibilities:
Reporting to: Head of Quality Assurance and Compliance
Role and responsibilities:
- Own and continuously improve the Quality Management System, driving updates and efficiencies rather than simply supporting them.
- Lead the management of customer complaints and other non-conformances, including root cause analysis and CAPA ownership through to close-out.
- Lead change control management, ensuring changes are appropriately assessed, documented and implemented in line with regulatory requirements.
- Own the development, review and updating of policies and standard operating procedures, ensuring they remain current and fit for purpose.
- Act as a key point of contact for customer questionnaires and health, safety, security, environment, quality and regulatory queries relating to products and services.
- Lead the internal audit programme, including risk assessment, scheduling, fieldwork, reporting and follow-up, and take ownership of audit outcomes.
- Lead and facilitate quality and HSSEQ audits, including hosting external and regulatory audits where required.
- Partner with the Q&C team and wider business to ensure the client meets all regulatory obligations across its products, services and industries served, providing subject matter expertise where needed.
- Mentor and support the development of other Q&C team members, sharing knowledge and best practice.
- Deputise for the Head of Quality Assurance and Compliance as required.
- Take on additional responsibilities assigned by Management from time to time.
- Relevant third-level qualification in a science, quality or related discipline.
- Minimum 5+ years' experience in a quality assurance and/or compliance role within pharma or an allied regulated industry, ideally including some experience leading audits, projects or process improvements.
- Strong working knowledge of quality management systems, deviations, CAPA, change control and root cause analysis.
- Proven ability to manage multiple priorities and competing deadlines in a fast-paced regulated environment.
- Confident liaising with and influencing external stakeholders including customers, suppliers and regulators.
- Track record of building strong, collaborative working relationships across teams.
- Experience supporting or mentoring junior colleagues, particularly within a Q&C function.
- Excellent verbal, written and interpersonal communication skills, with the ability to present to and influence senior stakeholders.
- Lean Six Sigma or similar process improvement qualification an advantage.
- Proficient in the Microsoft package.
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