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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.
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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 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
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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.
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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