GCP Auditor – Quality Assurance

Full Time
Germany
Posted 3 months ago

As Auditor you will perform Good Clinical Practice related audits in the areas of Clinical Operations, Medical Affairs, Regulatory Affairs, Translational Medicine, Biometrics and Data Management in various locations. This includes in-house document and process audits, audits at clinical sites and at Operating Units at the country and regional level, computer system validation audits as well as quality system audits at CROs and other service providers.

Tasks & responsibilities

  • Performing GCP related audits
  • Support the organisation in implementation and follow-up of corrective and preventive actions (CAPAs).
  • Provide business functions with QA and GCP guidance.
  • Understand quality by design and implement a risk based approach in the auditing process.
  • Prepare for and participate in regulatory inspections.
  • Share best practices and ideas with fellow auditors on international level, through the company network

Requirements

  • Master’s degree (or equivalent) in medicine, pharmacy, life science, or any other relevant field
  • Approximately 7 years’ experience in clinical trials with preferably 3 years’ experience in GCP Auditing
  • In-depth knowledge of GCP regulations and legal requirements, ideally also experience in quality management
  • Used to reviewing documents thoroughly and critically
  • Good communication skills in English (verbal and in writing), German language skills would be an asset
  • Well-developed interpersonal skills are required. Open-minded, reliable, and being able to work independently as well as in a team
  • Willingness to travel internationally, up to a maximum of 40%
Send your CV to JChandler@acr-uk.com using the job title as the email subject line