Détails de l'annonce
Publiée le:
26 janvier 2022
Type de poste:
Lieu de travail:
Tunis, Tunisie
Entre 5 et 10 ans
Bac + 3
Plein temps
Français , Anglais
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Secteur: recrutement / ressources humaines
Taille: Entre 200 et 500 employés
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.

Required Skills:

  • Minimum experience of 5 years on Quality Management system of GCP/GVP perimeters.
  • Previous experience as GCP and or GVP auditor will be a plus.
  • Knowledge of applicable regulations to GCP and GVP perimeters.
  • Knowledge of CVP and Medical device regulations are a plus.
  • Previous experience within pharmaceutical companies and/or Competent Authorities.
  • Expert on CAPA management activities.
  • Language: English.