Auditor - Cqa

CSL Behring

**
Clinical audit execution experience
Gcp regulatory knowledge ich e6
Risk categorization and capa development
** CSL Behring is seeking a CQA Auditor to join their Research & Development Quality audit program. The role involves conducting audits of clinical sites, ensuring compliance with regulatory standards, and supporting continuous improvement initiatives within the clinical trial framework. **

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 non-compliance trends and systematic risks within the Clinical GCP discipline to ensure trial robustness.
  • CSL Seqirus is part of CSL, one of the largest influenza vaccine providers in the world, offering state-of-the-art production facilities globally.

Matching Summary

Match Score: 75

** CSL Behring is seeking a CQA Auditor to join their Research & Development Quality audit program. The role involves conducting audits of clinical sites, ensuring compliance with regulatory standards, and supporting continuous improvement initiatives within the clinical trial framework. **

Skills & Requirements

Must-have

  • Clinical audit execution experience
  • GCP regulatory knowledge ICH E6
  • Risk categorization and CAPA development
  • Trend analysis in clinical trials
  • Global travel up to 50%

Nice-to-have

  • Collaborative stakeholder management
  • Strong negotiation skills
  • Analytical problem-solving abilities
  • Experience with multinational teams

Key Requirements

  • BS degree in biological science or related discipline
  • Quality assurance experience in GCP-regulated environment
  • Experience in clinical audit and inspection management

Work Rights

Not specified

Tailored Resume

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