Pharmaceutical Quality Assurance Position
About the Role
We are seeking an experienced quality assurance professional to join our team. As a Quality Auditor, you will be responsible for ensuring compliance with GMP/GDP regulations.
Key Responsibilities
* Plan, schedule, and conduct internal and external audits of manufacturers, suppliers, labs, warehouses, and transporters.
* Review documentation and quality processes to ensure adherence to HPRA, EU, and US standards.
* Assess quality systems (QMS), including document control, deviations, and CAPA management.
* Identify non-compliance issues, recommend corrective actions, and ensure timely follow-up.
* Prepare clear audit reports and communicate with stakeholders on CAPA plans.
* Contribute to continuous improvement of QMS, SOPs, and quality processes.
* Stay up-to-date on regulatory changes and best practices.
Qualifying Criteria
* Bachelor's degree in a science-related field.
* 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, organizational, and report-writing skills.
Additional Skills & Values
* A detail-oriented professional with leadership, influence, and engagement abilities.
* Strong problem-solving skills and ability to manage multiple priorities independently.
* A collaborative team player who drives engagement across the business.
This is a permanent position offering a dynamic work environment and opportunities for growth.