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Search Results for Quality Auditor
Job Title. Location Salary Actions

QA Senior Manager

Our client is an international biopharmaceutical drug discovery and development company, headquartered in Dublin, Ireland, focusing on new medicines for diseases which have a high unmet need. They are currently looking for a Senior QA Audit Manager with a proven track record in Quality Assurance; leading GCP audits and overseeing compliance with all GCP, GLP and GMP requirements. The successful candidate will be involved in maintaining, developing and continually improving the organisation’s Quality Management System and ensuring a Quality culture is present througho...

Location: Dublin,
QA Senior Manager
Dublin Not Disclosed
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QA Compliance Officer Galway Not Disclosed

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