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Quality Assurance Officer

Eurofins · Singapour

🇬🇧 English
Bioanalytical method validation

Job description

About the role

Eurofins Scientific is seeking a Quality Assurance Officer to ensure compliance and excellence across its laboratory operations. You will lead audits, inspections, and continuous improvement activities to uphold the highest standards in bioanalytical testing.

Key responsibilities

  • Plan, execute and report internal and external audits according to the audit timetable.
  • Conduct protocol, laboratory and data audits, and generate interim, draft and final reports.
  • Review raw data against draft bioanalytical study reports for accuracy and completeness.
  • Perform in‑life and operational spot inspections and produce associated reports.
  • Monitor corrective actions, ensure proper implementation and follow‑up.
  • Prepare, review and continuously improve QA procedures and SOPs.
  • Provide quality‑enhancement training and act as the primary contact for quality‑related queries.
  • Host client audits and regulatory inspections, and evaluate investigations and CAPA reports.

Required profile

  • Strong knowledge of bioanalytical method validation guidelines (FDA, EMA).
  • Familiarity with GCLP, GCP and related regulatory standards.
  • Experience conducting audits, inspections and CAPA management.
  • Ability to interpret raw data and produce clear, accurate documentation.

Required skills

  • Audit planning and execution
  • Bioanalytical method validation
  • FDA and EMA regulatory guidelines
  • GCLP and GCP compliance
  • CAPA (Corrective and Preventive Actions) management
  • SOP development and review

What we offer

  • Opportunity to work within a global leader in life‑science testing.
  • Collaborative environment with continuous learning and development.
  • Exposure to a wide range of analytical methods and regulatory frameworks.

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Published 3 months ago

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Eurofins

Singapour