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QA Senior Manager Dublin Not Disclosed



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Quality Auditor Career Profile

Quality Auditor - Clinical Research


This is an interesting position which involves ensuring overall Quality in a Clinical Research Organisation (CRO) environment. It is a role which involves a lot of travel to various Client and supplier sites. A keen eye for detail and skill in dealing with people in required.

Main Responsibilities

  • Conducting investigator site and CRO audits
  • Carrying out the Audit of internal GCP tasks and departments
  • The maintenance of the audit log and global audit plan
  • Act as the sole Clinical QA representative on study teams that are assigned to your control
  • Performing Study document compliance audits
  • Provide GCP training to colleagues

Skills/Experience

  • A degree in health sciences, nursing, pharmacy or related field
  • Extensive experience in carrying out GCP audits in the EU inline with FDA/EMEA/global regulatory requirements and to GCP guidelines
  • A willingness to travel up to 50% of the time

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