Job Description
We are seeking an experienced Quality Auditor to join our team and support compliance with GMP/GDP regulations in a fast-paced, dynamic pharmaceutical company.
This is a permanent job based in Westmeath, offering strong scope for impact and the opportunity to work with quality systems (QMS), including document/change control, deviations, and CAPA management.
The successful candidate will have experience conducting internal and external audits, reviewing documentation to ensure compliance with HPRA, EU, and US GMP/GDP standards.
* Plan, schedule, and conduct internal and external audits (manufacturers, suppliers, labs, warehouses, transporters)
* Review documentation and quality processes to ensure compliance with regulatory requirements
* 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
Required Skills and Qualifications
The ideal candidate will have:
* Experience conducting internal and external audits
* Familiarity with HPRA, EU, and US GMP/GDP standards
* Strong analytical and problem-solving skills
* Excellent communication and interpersonal skills
Benefits
This role offers a competitive salary and benefits package, including:
* A permanent position in a dynamic pharmaceutical company
* The opportunity to work with quality systems and regulatory compliance
* A supportive and collaborative team environment