Auditor - Cqa

CSL Seqirus

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Clinical trial audit execution
Gcp regulatory knowledge ich e6
Capa development and risk categorization
** CSL Seqirus is seeking an experienced CQA Auditor to execute audits within their Research & Development Quality audit program, ensuring compliance with clinical trial regulations. The ideal candidate should possess a strong background in quality assurance in GCP-regulated environments and have excellent communication and problem-solving skills. **

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 is part of CSL, one of the largest influenza vaccine providers in the world with a strong commitment to inclusion and belonging.

Matching Summary

Match Score: 75

** CSL Seqirus is seeking an experienced CQA Auditor to execute audits within their Research & Development Quality audit program, ensuring compliance with clinical trial regulations. The ideal candidate should possess a strong background in quality assurance in GCP-regulated environments and have excellent communication and problem-solving skills. **

Skills & Requirements

Must-have

  • Clinical trial audit execution
  • GCP regulatory knowledge ICH E6
  • CAPA development and risk categorization
  • Trend analysis for non-compliance
  • SOP improvement initiatives

Nice-to-have

  • Collaborative stakeholder engagement
  • Multinational team navigation
  • Systemic stability focus
  • Strong negotiation skills

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 with up to 50% global travel

Work Rights

Not specified

Tailored Resume

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