Pharmaceutical Industry QA Specialist

4 days ago

Dublin, Dublin City, Ireland beBeeAuditor Full time €69,000 - €87,000
Quality Assurance Specialist - Pharmaceutical Industry

We are seeking an experienced Quality Assurance Specialist to ensure compliance with regulatory standards in the pharmaceutical industry.

This role is responsible for planning, scheduling and conducting internal and external audits of manufacturers, suppliers, labs, warehouses and transporters. The ideal candidate will have a strong knowledge of GMP/GDP regulations and experience in quality assurance or compliance.

Key Responsibilities:
  • Conduct Audits: Plan, schedule and conduct internal and external audits of manufacturing facilities, suppliers, labs, warehouses and transporters to ensure compliance with GMP/GDP regulations.
  • Review Documentation: Review documentation and quality processes to ensure compliance with HPRA, EU and US GMP/GDP standards.
  • Assess Quality Systems: Assess quality systems, including document change control, deviations and CAPA management.
  • Identify Non-Compliance Issues: Identify non-compliance issues, recommend corrective actions and ensure timely follow-up.
Required Skills and Qualifications:
  • Bachelor's Degree: Bachelor's degree in a science-related discipline.
  • Experience: 5+ years' experience in quality assurance or compliance in the pharmaceutical industry.
  • Auditing Experience: Proven auditing experience in GMP/GDP environments.
  • Regulatory Knowledge: Strong knowledge of HPRA, EU and US regulations.
  • Communication Skills: Excellent communication, organisational and report-writing skills.
Additional Skills & Values:
  • Problem-Solving Skills: Strong problem-solving skills and the ability to manage multiple priorities autonomously.
  • Team Player: A collaborative team player who can drive engagement across the business.

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