About the job

We are looking for a Compliance officer to support our client in management of CAPAs related to GCP and Vigilance audits.

About us

Group 10
Responsibilities

  • 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
  • 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 related to audit management and follow-up
  • Audit quality document updates

Group 11
Education and Experience

  • 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

 

Group 13
Skills

 

  • Good English language skills
  • Proactive to predict issues and solve problems,
  • Ability to establish excellent working relationships
  • Excellent planning and prioritization skills.

 

Compliance Officer (CAPA Management) 589