Auditor - Cqa

CSL SEQIRUS

Not specified, but the role involves up to 50% global travel.
Clinical audit execution experience
Gcp regulatory knowledge ich e6
Capa development and risk categorization
CSL Seqirus is seeking an experienced CQA Auditor to support its Research & Development Quality audit program, focusing on the compliance and integrity of clinical trial data. The ideal candidate will possess strong auditing skills within GCP-regulated environments, coupled with excellent communication and organizational abilities

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 external vendors and sites.
  • CSL Seqirus is one of the largest influenza vaccine providers in the world with state-of-the-art production facilities in the U.S., U.K., and Australia.

Matching Summary

Match Score: 85

CSL Seqirus is seeking an experienced CQA Auditor to support its Research & Development Quality audit program, focusing on the compliance and integrity of clinical trial data. The ideal candidate will possess strong auditing skills within GCP-regulated environments, coupled with excellent communication and organizational abilities.

Skills & Requirements

Must-have

  • Clinical audit execution experience
  • GCP regulatory knowledge ICH E6
  • CAPA development and risk categorization
  • Trend analysis for non-compliance
  • Global travel up to 50%

Nice-to-have

  • Excellent interpersonal negotiation skills
  • Collaborative stakeholder management
  • Continuous improvement initiative support

Key Requirements

  • BS degree in biological science or related discipline
  • Quality Assurance experience in GCP-regulated environment
  • Experience in clinical audit and inspection management
  • Strong analytical and problem-solving skills

Work Rights

Not specified

Tailored Resume

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