Job Title: Quality Auditor
We are seeking an experienced Quality Auditor to support compliance with GMP/GDP regulations in a dynamic pharmaceutical company.
* This permanent role is based in Athlone, offering the opportunity to work in a fast-paced environment with strong scope for impact.
Key Responsibilities:
Audit Planning and Execution
Plan, schedule, and conduct internal and external audits (manufacturers, suppliers, labs, warehouses, transporters) to ensure compliance with HPRA, EU, and US GMP/GDP standards.
Review documentation and quality processes to identify non-compliance issues and recommend corrective actions.
Quality System Management
Assess quality systems (QMS), including document/change control, deviations, and CAPA management, to ensure adherence to regulatory requirements.
Identify areas for improvement and contribute to continuous enhancement of QMS, SOPs, and quality processes.
Regulatory Knowledge and Compliance
Maintain up-to-date knowledge of regulatory changes and best practices in the pharmaceutical industry.
Liaise with stakeholders on CAPA plans and prepare clear audit reports.
Requirements
Bachelors 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.
Benefits
A collaborative team player who can drive engagement across the business.
Strong problem-solving skills and the ability to manage multiple priorities autonomously.
A detail-oriented professional with the ability to lead, influence, and engage teams.