Clinical Auditing Specialist III

3 weeks ago


Athlone, County Westmeath, Ireland Thermo Fisher Scientific Full time
:

Perform risk based review of highly complex validated systems

Lead directed site audits, facility, vendor, and/or sub-contractor audits

Provide GxP consultation and support to project teams and external clients

Lead process audits and may participate as a co-auditor in more complex system audits

Perform other types of QA audits or activities such as internal audits, non-conformance review and investigation review.

Serve as a resource to operational departments on audit or quality assurance subject matter

Prepare and present audit findings and related information at departmental, internal operations, or client meetings

Attend site as required in order to perform client audits, regulatory inspections, internal audits and other activities as required

Provide mentorship and guidance to junior auditors

Requirements:

Bachelor's degree in a related field

Minimum of 5 years of experience in clinical auditing or quality assurance

Strong knowledge of GxP regulations and guidelines

Exceptional attention to detail and ability to ensure flawless execution of audits

Proven ability to successfully implement audit processes and procedures

Excellent communication and presentation skills

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.



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