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Senior QA GCP Auditor

2 months ago

Remote Work, United Kingdom CK Group- Science, Clinical and Technical Full time
Senior QA GCP Auditor

CK Group is seeking a highly experienced Senior QA GCP Auditor to join our team. As a Senior QA GCP Auditor, you will be responsible for ensuring full GCP and GCLP compliance across all clinical trial activities in the UK and EU.

Key Responsibilities:
  • Execution of internal audits and mock inspections
  • Execution of external audits of CROs, clinical laboratories, TMFs, and investigational sites
  • Management of the audit process from start to finalization of audit reports
  • Training staff on clinical aspects of drug development, general medical knowledge related to the conduct and monitoring of oncology trials, and the mechanism of action and known risks of drugs under study
Requirements:
  • Extensive GCP audit experience for IMPs gained in a sponsor company or CRO
  • Clinical operations experience in CRA, CPM, or similar roles
  • Willingness to travel in the UK or EU, typically two audits per month
  • An in-depth knowledge of ICH-GCP requirements and the drug development process
  • Provision of training for GCP/GCLP regulations and procedures under UK and EU requirements
Benefits:
  • Up to £68,000 per annum plus car allowance and bonus

Location: Home based in the UK