Description de l'annonce:

• Main activities:

  Management of CAPAs related to GCP and Vigilance audits from their validation by the Lead auditor or Oversight auditors team, follow-up until their closure according to IRIS/LLS procedures.
• Collect of the CAPAs or CAPA plan approved by the Lead Auditor or the oversight auditor (in case of audit conducted by a service provider).
• Collect any CAPAs or CAPA plan follow-up from the audit responders.
• Review the proposed follow-up actions and any associated evidences of action implementation provided.
• If actions may be closed, document the close-out of the action.
• If actions may not be closed, document the review and expectations.
• If actions may be not completed, assess if the modification can be accepted.
• Extension of due date should be not accepted systematically and only in special circumstances. In such case, initial CAPA due date is maintained.
• Monitor the CAPA due date and in case of CAPA due date passed, request the CAPA or CAPA plan follow-up.
• Escalate any CAPAs or CAPA plan overdue.
• Document the CAPA review of Major and Critical Findings through the CAPA system tool.
• Document the CAPA review of minor Findings through a specific CAPA system tool.
• File the documentation in the concerned share point.
• In case of workload, data enter the CAPAs in the centralised database.
• Periodic reporting to the Head of audit department of CAPA closure progress.
• List of CAPAs open, closed, overdue.
• List of audits open and closed since the previous reporting.
• Any other activity linked to the management of deviations/CAPAs related to GVP/Vigilance audits.