A rare opportunity has risen for an experienced individual to join a global CRO at a senior level. This opportunity will allow you to provide management of the Quality Assurance program. Your strategic input wouldn't be undervalued! You will be liaising across different departments of the business to assure consistency with policies and procedures.
About the role:
The role can be office or home-based
The Principal Quality Assurance Auditor will report the Head of QA .
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Plan and set up the annual quality audit programme .Ensure the quality audit programme is followed and kept up to date .
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You should have expertise and experience: GCP and CSV QA experience Experience with assisting and managing QA audits and inspections as well as interfacing with regulatory agencies.
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Conduct reporting and follow-up of quality system, computer system validation and service provider audits .
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Record the Audits results and reported and that corrective/preventative actions are documented .
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Maintain the approved service provider list .
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Oversee production of the monthly QA report to management using QA metrics and escalate any issues for concern to the Head of QA, Production of the annual trend analysis using QA metrics .
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Produce training documentation relating to quality and regulatory areas (if required).
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Participate in Client audits and regulatory Inspections (preparation, hosting, responses and follow up of corrective action plans)
Do reach out to me at or +44 07771 976356