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QA Specialist – GMP Compliance

Proclinical Staffing · Waterford

🇬🇧 English
cGMP GMP

Job description

About the role

Join a dynamic team in Ireland as a QA Specialist, ensuring that all products are manufactured, stored and packaged in strict compliance with cGMP standards. You will support quality systems, conduct audits and drive continuous improvement across the organization.

Key responsibilities

  • Develop and deliver GMP training packages.
  • Prepare, review and maintain procedures and batch documentation.
  • Conduct scheduled audits across departments and support internal, supplier and regulatory audits.
  • Act as the quality point of contact, providing guidance on systems, processes and quality issues.
  • Review investigations, reports and documentation, addressing concerns based on risk.
  • Collaborate with other departments to close quality actions and findings promptly.
  • Report Right First Time (RFT) data trends and contribute to continuous‑improvement initiatives.
  • Investigate product deviations and ensure resolution before release.

Required profile

  • A degree in a scientific discipline (preferred) or equivalent experience.
  • Previous experience in a GMP‑regulated environment.
  • Strong knowledge of cGMP and relevant regulatory standards.
  • Excellent attention to detail, accuracy and interpersonal skills.
  • Self‑motivated, results‑driven and able to work with minimal supervision.

Required skills

  • cGMP
  • GMP
  • Audit execution

What we offer

  • Opportunity to work in a regulated, high‑impact environment.
  • Professional development and continuous‑improvement projects.

Questions fréquentes

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Published 2 months ago

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Proclinical Staffing

Waterford