QA Auditor I/ll
About the role
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- Plan and conduct regular and random internal QA audits in order to assure that all studies managed by ICON are of the highest standard and are in compliance with the requirements of ICON or Sponsor SOPs, study protocols, relevant regulations and guidelines. These will include in-process study inspections, data audits as well as table and report audits.
- Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented.
- When appointed lead auditor, perform the duties assigned in an efficient and effective manner. This includes liaison with the operations and/or operational lead on all QA issues, including audit planning and review of audit results.
- Verification of audit CAPA completion where required by procedure.
- Keep the person whom the QA Auditor reports to informed of any QA issues within the department that require attention.
- Assist with preparation, conduct and follow up of Sponsor and Regulatory audits.
- Review, assess, distribute and coordinate response for external audit reports to the appropriate departments – ensure CAPA follow-up is documented and reported to Management.
- Participate in managing the recording, investigation, tracking and resolution of any Quality Issues.
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