Quality Assurance Auditor

Scope of the job

The Quality Assurance Auditor is working within the Quality Assurance & Control Unit, performing audits within European countries, but also involved in monitoring activities

Main responsibilities / Major Activities

QA activities:

  • Perform sites and third parties audits, according to the Audit program
  • Create the audit report, CAPA, and audit certificate, after each audit
  • Ensure adequate follow up of the audit observations (major and critical)
  • Perform compliance visits in the frame of Intergroup trials coordinated by US Group
  • Escalate serious quality issues to Head of QA&C Unit
  • Participate in the preparation and follow up of sponsor audits and Regulatory Authorities inspections at EORTC HQ and EORTC institutions, when necessary
  • Maintain the procedures and templates related to external audit
  • Provide support and advice to HQ staff in case of GCP issues

Monitoring activities:

  • Coordination of internal and/or external monitoring activities (i.e. monitoring reports review, advice on actions, tracking of visits schedule)
  • Perform co-monitoring visits, whenever needed
  • Provide assistance to the CRAs in the management of non-compliance issues

Support to Head of QA&C unit:

Support the Head of QA&C in the ongoing activities and ensure his back-up in case of absence

Profile

  • University degree or equivalent in Health Sciences
  • Minimum one year of experience as GCP auditor
  • Practical knowledge of the conduct of clinical trials
  • Ability to travel across European countries

 

Skills

  • Analytical mindset
  • Excellent organization
  • Good communication skills
  • Proactive, dynamic
  • Capable of working autonomously and inside a team
  • Flexible attitude with respect to work assignments and new learning
  • Fluent in English (oral and written)

Application form


*Compulsary fields
Application should be sent in English

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