Description
Our client, a medical device company is currently looking for a French speaking CAPA Consultant for a contract/freelance position based in South East France.The site is currently undergoing a large remediation project and recognises they are behind their schedule with the amount of CAPAs they have open. They have a backlog of open CAPAs that need addressing and therefore the team require a senior CAPA consultant with previous experience of medical device/pharma remediation projects.
Tasks:
Support the implementation of the standardised procedures, processes and systems for CAPA.
Deliver education and interactive training for CAPA users to deliver consistent compliant CAPAs including Failure Investigation, CAPA Review Board and CAPA content.
Assist CAPA users with development and documentation of problem statements, containment and correction, root cause, and action plan (including effectiveness monitoring) determination.
Maintain overall management and effectiveness of the CAPA system including the process and application for the site.
Roll-out and maintain site CAPA Review Boards including scheduling, execution and minutes.
Ensure processes are in place to alert management of product quality & compliance issues for proper and timely escalation to CAPA.
Provide CAPA compliance metrics and weekly management tracking report.
Implement measures to monitor the effectiveness of the CAPA system. Ensure results of verification and monitoring of the effectiveness of CAPA and its compliance with applicable regulations and standards of monitoring process are routinely communicated to management.
Facilitate Change Management activities resulting from the standardisation of the CAPA process and associated systems.
Liaise with the Head of Compliance to align on system requirements to support the CAPA process.
Identification and leadership of tactical continuous improvement opportunities.
Partner on the formulation of responses to regulatory agencies in order to address CAPA related observations. Collaborate in the identification and implementation of corrective actions. Ensure effective and timely completion of all corrective actions.
Challenge SMEs on their existing processes and suggest improvements.
Must Have Experience:
- CAPA knowledge
- Remediation Project experience
- Senior QA experience within FDA regulated environment
- French Speaking is a must