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Search Results for Quality Auditor
Job Title. Location Salary Actions

QA Representative API External Manufacturing

QA Representative API External Manufacturing Our client, a global manufacturing pharma organisation, are currently recruiting for a QA Representative to join their Cork based team on a permanent basis. As QA Rep, you will provide support for the quality activities at Contract Manufacturing organizations (CMOs). This role will involve international travel to ensure that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. Around 20% travel is anticipated. Responsibilities S...

Location: Cork,
QA Representative API External Manufacturing
Cork 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