Quality Assurance Specialist

19 hours ago

Mullingar, Ireland beBeeAuditing Full time €60,000 - €80,000
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.

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