Quality Assurance Auditor 1 - GCP - South AfricaICON plc is a world-leading healthcare intelligence and clinical research organization. Were 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 developmentAt ICON, its our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients lives.Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.Thats our vision. Were driven by it. And we need talented people who share it.
If youre as driven as we are, join us. Youll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and youll be helping shape an industry.Our Quality Assurance Auditor will assess the compliance of ICON Laboratories to all federal/state of New York, US FDA GLP regulations, ICH E6(2) regulations, adherence to Guidance for Industry documents and ICON quality standards as well as assist with developing Standard Operating Procedures.The Role:Lead KOM with internal teams for Site Audit finding review.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 review of audit responses, where applicable.Support Internal teams with Site Audit response management within ICONs ACMS.Verification of audit CAPA completion where required by procedure.Review work instructions and procedures, contributing to continuous improvement.Keep the person whom the QA Auditor reports to informed of any QA issues within the department that require attention.What you need:
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