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Quality Technician

Cambrex · Waterford

🇬🇧 English
cGMP QMS eQMS CAPA audit

Job description

About the role

The Quality Technician will support Cambrex’s Quality Management System (QMS) and ensure compliance with cGMP standards. Reporting to the Quality Manager for Waterford, the role is central to maintaining product quality and regulatory adherence across the site.

Key responsibilities

  • Provide assistance and advice on all QMS activities and ensure Q1 activities meet company quality standards.
  • Monitor the QMS, suggest improvements, and implement corrective and preventive actions (CAPA).
  • Investigate and document planned and unplanned changes (deviations) thoroughly.
  • Review completed documents for compliance, maintain electronic and hard‑copy indexes, and issue controlled document numbers.
  • Support eQMS administration and collaborate with cross‑functional teams.
  • Coordinate and prepare for internal, regulatory, supplier, and customer audits, and report audit findings.

Required profile

  • Strong attention to detail and excellent organizational abilities.
  • Ability to work independently and as part of a team in a regulated environment.
  • Effective communication skills for documenting and reporting findings.

Required skills

  • Knowledge of cGMP standards.
  • Experience with Quality Management Systems (QMS) and electronic QMS (eQMS).
  • Familiarity with CAPA processes.
  • Document control and audit preparation.

What we offer

  • Competitive benefits package including healthcare, life insurance, and retirement planning.
  • Opportunities for professional development in a fast‑growing CDMO environment.
  • Collaborative culture focused on safety, quality, and continuous improvement.

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Published 2 months ago

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Cambrex

Waterford