Gauthier Van Thuyne Brument

- Assist and advise the various departments of the factory in the application of the quality management system and continuous improvement

- Ensure awareness and training of the relevant departments on quality

- Review production files and release products subject to batch files.

- Evaluate and conduct investigations on quality problems (deviations, OOS, complaints)

- Evaluate change requests

- Propose, implement and/or monitor the execution of improvement actions (corrective and preventive actions) and changes

- Monitor the handling of non-conforming products

- Conduct internal audits as part of the quality management system surveillance activities

- Contribute to the drafting and approval or review of quality documentation (procedures, instructions, manufacturing sheets, records...). Ensure its management and archiving

- Grant derogations in compliance with the rules in force on site ==>

- Supervise complaint follow-up

- Ensure awareness and training of the production department on quality

- Review production files

- Evaluate and conduct investigations on quality problems

- Propose, implement and/or monitor the execution of improvement actions (corrective and preventive actions)

- Conduct field audits as part of the quality management system surveillance activities

- Contribute to the drafting and approval or review of quality documentation (procedures, instructions, manufacturing sheets, records...). Ensure its management and archiving

- Replacement of the team leader to ensure production monitoring

Missions: supplier qualification, raw material approval files per manufacturer, participation in ANSM and Russia inspections, client audits, ICH Q3D guideline with risk analysis establishment, supplier document audits, annual audit planning to be created with budget limitations for supplier audits.