GVP Auditor

4 weeks ago


United Kingdom Qualitas Full time

We are currently searching for a remote GVP auditor to join an international CRO. The role will be responsible for deliverly of pharmacovigilance services to their clients including glbal pharma and biotech companies. Responsiblities

  • Prepares and performs audits on behalf of clients and relevant reporting to them
  • Assists clients in supporting their Annual Audit plan
  • Collaborates with the QA Director to manage the external Auditors and engage them as appropriate
  • Develops the workflow Contributes to the team to ensure that Quality & Projects Plans are developed according to the client’s requirements
  • Collaborates with the team for the development of standard operating procedures and work guidance and/or reviews client’s SOPs if applicable, to ensure full compliance
  • Assists clients in preparing documentation for audit/inspection readiness
  • Contributes to ensuring tracking of compliance metrics
  • Assists clients in identifying and up following up on corrective action plans arising from audits and inspections
Experience
  • Scientific degree
  • 3+ years experience conducting GVP audits
  • Fluent English
  • in depth knowledge of GVP regulations

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