Clinical Auditing Specialist III, Athlone

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Clinical Auditing Specialist III, Athlone

Job Description:

1. Perform risk based review of highly complex validated systems.
2. Lead directed site audits, facility, vendor, and/or sub-contractor audits.
3. Provide GxP consultation and support to project teams and external clients.
4. Lead process audits and may participate as a co-auditor in more complex system audits.
5. Perform other types of QA audits or activities such as internal audits, non-conformance review and investigation review.
6. Serve as a resource to operational departments on audit or quality assurance subject matter.
7. Prepare and present audit findings and related information at departmental, internal operations, or client meetings.
8. Attend site as required in order to perform client audits, regulatory inspections, internal audits and other activities as required.
9. Provide mentorship and guidance to junior auditors.

1. Bachelor's degree in a related field.
2. Minimum of 5 years of experience in clinical auditing or quality assurance.
3. Strong knowledge of GxP regulations and guidelines.
4. Exceptional attention to detail and ability to ensure flawless execution of audits.
5. Proven ability to successfully implement audit processes and procedures.
6. Excellent communication and presentation skills.