Senior QA Auditor

4 weeks ago

Sydney, New South Wales, Australia Pharmiweb Full time
Job Title: Senior QA Auditor

About the Role:

We are seeking a highly skilled Senior QA Auditor to join our team. As a Senior QA Auditor, you will be responsible for leading and supporting external audits of ICON, including scheduling, preparation, and hosting. You will also be responsible for leading CAPA management for external audits of ICON and/or investigator sites, where needed.

Key Responsibilities:

Leading and supporting external audits of ICON, including scheduling, preparation, and hosting.

Leading CAPA management for external audits of ICON and/or investigator sites, where needed.

Leading quality issue investigations, including ensuring appropriate root cause analysis is performed, and adequate corrective and preventative actions are implemented.

Ensuring CAPAs are formally recorded and reported and actions are documented and followed until resolution.

Requirements:

Knowledge/experience in hosting external audits and/or regulatory inspections.

Knowledge/experience in CAPA management, including performing effective root cause analysis.

Ability to review and evaluate clinical data/records.

Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators, and clients.

Detailed understanding of drug development and clinical trial process.

Good problem resolution skills.

Good planning and organizational skills with the ability to multi-task and prioritize effectively.

What We Offer:

Competitive salary and benefits package.

Opportunity to work with a leading healthcare intelligence and clinical research organization.

Collaborative and dynamic work environment.

Professional development opportunities.

How to Apply:

If you are a motivated and experienced QA professional looking for a new challenge, please submit your application.

About ICON:

ICON is a world-leading healthcare intelligence and clinical research organization. We are proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Equal Opportunities Employer:

ICON is an equal opportunities employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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