Auditor - Cqa

cslbehring.cl

Not specified (assumed hybrid due to the mention of travel).
Clinical trial audit execution
Gcp regulatory knowledge ich e6
Capa development and risk categorization
CSL Behring is seeking a CQA Auditor to join their Research & Development Quality audit program, responsible for executing global audit plans to ensure compliance and accuracy in clinical trial data. The ideal candidate will have quality assurance experience in GCP-regulated environments and strong communication skills, with a focus on continuous improvement and regulatory knowledge in clinical research

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 focus on pandemic preparedness.

Matching Summary

Match Score: 85

CSL Behring is seeking a CQA Auditor to join their Research & Development Quality audit program, responsible for executing global audit plans to ensure compliance and accuracy in clinical trial data. The ideal candidate will have quality assurance experience in GCP-regulated environments and strong communication skills, with a focus on continuous improvement and regulatory knowledge in clinical research.

Skills & Requirements

Must-have

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

Nice-to-have

  • Collaborative stakeholder engagement
  • SOP improvement initiatives
  • Multinational team communication skills

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

Cover Letter