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