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CSL Seqirus is seeking a CQA Auditor to join their Research & Development Quality audit program, responsible for executing audits to ensure compliance with clinical trial standards. The ideal candidate will possess strong quality assurance experience in a GCP-regulated environment, with excellent communication skills and the ability to analyze compliance trends.
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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 fosters a culture of inclusion and belonging where celebrating differences fuels innovation day in and day out.
Matching Summary
Match Score: 75
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CSL Seqirus is seeking a CQA Auditor to join their Research & Development Quality audit program, responsible for executing audits to ensure compliance with clinical trial standards. The ideal candidate will possess strong quality assurance experience in a GCP-regulated environment, with excellent communication skills and the ability to analyze compliance trends.
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Skills & Requirements
Must-have
Clinical Quality Assurance experience
GCP regulations knowledge ICH E6
Global audit execution capability
Risk categorization and CAPA development
Trend analysis for non-compliance
Nice-to-have
Collaborative stakeholder engagement skills
Strong analytical problem-solving abilities
Experience with multinational clinical teams
Ability to work with limited supervision
Commitment to systemic stability
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 including up to 50% global travel