We are seeking an experienced Quality Auditor to join our client’s team and support compliance with GMP/GDP regulations. This permanent job based in Athlone, Co.Westmeath, offering the opportunity to work in a fast-paced, dynamic pharmaceutical company with strong scope for impact.
Key Responsibilities:
- Plan, schedule, and conduct internal and external audits (manufacturers, suppliers, labs, warehouses, transporters).
- Review documentation and quality processes to ensure compliance with HPRA, EU, and US GMP/GDP standards.
- Assess quality systems (QMS), including document/change control, deviations, and CAPA management.
- Identify non-compliance issues, recommend corrective actions, and ensure timely follow-up.
- Prepare clear audit reports and liaise with stakeholders on CAPA plans.
- Contribute to continuous improvement of QMS, SOPs, and quality processes.
- Stay updated on regulatory changes and best practices.
Qualifying Criteria:
- Bachelor’s degree in a science-related discipline.
- 5+ years’ experience in quality assurance or compliance in the pharmaceutical industry.
- Proven auditing experience in GMP/GDP environments.
- Strong knowledge of HPRA, EU, and US regulations.
- Solid understanding of manufacturing and lab processes, validation, and distribution.
- Excellent communication, organisational, and report-writing skills.
Additional Skills & Values:
- A detail-oriented professional with the ability to lead, influence, and engage teams.
- Strong problem-solving skills and the ability to manage multiple priorities autonomously.
- A collaborative team player who can drive engagement across the business.
For a confidential discussion about this opportunity, please contact Ranait Coughlan
ranait.coughlan@collinsmcnicholas.ie
(090) 6450664 (01) 66 200 8