Détails de l'annonce
Référence
148916
Date de publication
5 février 2022
Type de contrat
CDILieu de travail
Tunis, Tunisie
Expérience requise
Entre 5 et 10 ans
Niveau d'études
Bac + 3
Disponibilité
Plein temps
Langues
Français Anglais
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Entreprise
PRODUCTLIFE GROUP
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.
