Auditor - Cqa

CSL Seqirus

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Clinical quality assurance experience
Gcp regulations knowledge ich e6
Global audit execution capability
** CSL Seqirus is seeking a CQA Auditor to join their Research & Development Quality audit program, responsible for executing audits to ensure compliance with clinical trial standards. The ideal candidate will possess strong quality assurance experience in a GCP-regulated environment, with excellent communication skills and the ability to analyze compliance trends. **

Job Summary

  • This role serves as a CQA Auditor responsible for executing the global audit plan to ensure the accuracy of clinical trial data.
  • The position requires identifying findings and non-compliance trends that could impact the integrity of clinical research across various stakeholders.
  • CSL Seqirus fosters a culture of inclusion and belonging where celebrating differences fuels innovation day in and day out.

Matching Summary

Match Score: 75

** CSL Seqirus is seeking a CQA Auditor to join their Research & Development Quality audit program, responsible for executing audits to ensure compliance with clinical trial standards. The ideal candidate will possess strong quality assurance experience in a GCP-regulated environment, with excellent communication skills and the ability to analyze compliance trends. **

Skills & Requirements

Must-have

  • Clinical Quality Assurance experience
  • GCP regulations knowledge ICH E6
  • Global audit execution capability
  • Risk categorization and CAPA development
  • Trend analysis for non-compliance

Nice-to-have

  • Collaborative stakeholder engagement skills
  • Strong analytical problem-solving abilities
  • Experience with multinational clinical teams
  • Ability to work with limited supervision
  • Commitment to systemic stability

Key Requirements

  • BS degree in biological science or related discipline
  • Quality Assurance experience within GCP-regulated environment
  • Experience in clinical audit and inspection management
  • Ability to manage schedule including up to 50% global travel

Work Rights

Not specified

Tailored Resume

Cover Letter