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Quality Assurance Associate - ANZ

Clinigen · Warriewood

🇬🇧 English
GDP GMP quality risk assessment CAPA

Job description

About the role

The Quality Assurance Associate will support operational excellence across Link's ANZ warehouse facilities, ensuring compliance with ISO, GDP and GMP standards and local regulations.

Key responsibilities

  • Review and approve product releases for distribution, verifying all GDP and regulatory requirements are met.
  • Manage customer approvals, complaints, returns, and temperature excursions, documenting investigations and corrective actions.
  • Prepare monthly quality reports, analyse trends, and present findings to management.
  • Support internal and external audits, maintain the approved supplier list, and drive training on GDP, GMP and SOPs.
  • Collaborate with stakeholders to resolve quality issues and drive continuous improvement.

Required profile

  • Tertiary qualification in a technical discipline or equivalent experience.
  • Experience in pharmaceutical operations and working within GDP/GMP quality management systems.
  • Ability to build cross‑functional relationships and work autonomously.

Required skills

  • Strong knowledge of GDP and GMP requirements.
  • Proficiency with quality risk assessment and corrective‑preventive action processes.
  • Advanced computer skills and familiarity with standard QA software tools.

Questions fréquentes

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Source : ats:workable

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Published 3 weeks ago

Expires 1 month from now

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Clinigen

Warriewood