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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.
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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
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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.
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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