Job Overview
We are seeking an experienced Quality Assurance Specialist to support compliance with GMP/GDP regulations in a fast-paced, dynamic pharmaceutical company.
About the Role
* 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.
* Assess quality systems (QMS), including document/change control, deviations, and CAPA management.
* Prepare clear audit reports and liaise with stakeholders on CAPA plans.
* Contribute to continuous improvement of QMS, SOPs, and quality processes.
Requirements
* 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.
Key Responsibilities
* Solid understanding of manufacturing and lab processes, validation, and distribution.
* Excellent communication, organisational, and report-writing skills.
* A detail-oriented professional with the ability to lead, influence, and engage teams.
About Us