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Senior QA GCP Auditor

3 months ago

London, United Kingdom CK Group Full time
CK Group are looking for a Senior QA GCP Auditor to join a successful global pharmaceutical company. This will be a field-based typically performing two UK / EU audits per month.

RESPONSIBILITIES:
As Senior QA GCP Auditor you will ensure full GCP and GCLP compliance across all the companies clinical trial activities in the UK and EU.

Key duties will include:
  • Execution of internal audits and mock inspections.
  • Execution of external audits of CROs, clinical laboratories, TMFs, Investigational sites etc.
  • Management of the audit process from start to finalisation of audit reports.
  • Training staff on the 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.

QUALIFICATIONS:

As Senior QA GCP Auditor you will require:
  • Extensive GCP audit experience for IMPs gained in a sponsor company or CRO.
  • Clinical operations experience in CRA, CPM or similar roles.
  • Willing 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 plus car allowance and bonus.

Location:
Home based in the UK

Apply:

It is essential that applicants hold entitlement to work in the country you will be working in. Please quote job reference 104245 in all correspondence.