À propos de Virginie
Français
Bilingue ou natif
Anglais
Capacité professionnelle complète
Expériences
- EmboFlu–Medical deviceQuality EngineerINDUSTRIE PHARMACEUTIQUEavril 2025 - juillet 2025 (3 mois)Gland, VD, Switzerland• Management and Administration of QC process, Responsible for the particles and microbiological monitoring of clean environments, recording, and reporting pest control.• Management and Administration calibration and maintenance process, Supervise the preventive maintenance and calibration of production equipment/tools.• Batch release: Ensure post-production batch release• Quality Assurance Documentation and Training: Active contribution to the development of Quality Assurance SOPs, as well as the implementation of targeted training for relevant activities.• Risk Analysis: Active participation on QC process risk analysis.
- Merz Aesthetics, Anteis SA – Medical deviceQuality EngineerINDUSTRIE PHARMACEUTIQUEavril 2018 - juillet 2024 (6 ans et 3 mois)Lonay, VD, Switzerland• Management and Administration of complaints process, quality issue investigation, sample return inspection, documented complaints in database for trend tracking and analysis.• Management and Administration change requests process in accordance with applicable procedures and standards.• Performance Reporting and Analysis: Development of key performance indicators for activity tracking, contributing to informed and proactive decision-making.• Audit and Regulatory Compliance: Preparation and support during audits and inspections, active participation in the internal audit program as a qualified auditor.• Quality Assurance Documentation and Training: Active contribution to the development of Quality Assurance SOPs, as well as the implementation of targeted training for relevant activities.• Post-Market Surveillance - Risk Analysis: PMS Participation, providing data from complaints management, change requests, and risk analysis processes.
- MindMazeQuality EngineerSECTEUR MÉDICALjuin 2016 - février 2018 (1 an et 8 mois)Lausanne, Switzerland• Quality Assurance Documentation: Developing and updating of product/process documentation, validation reports, change requests, and quality records.• Internal training on Quality System requirements (QMS).• Audit and Regulatory Compliance: Conducting internal audits, Assisting with certification audits, and FDA inspections.• Supplier complaints management: Developing control plans and managing supplier claims.• Customer complaints management: Investigating and implementing actions plans.• Management and tracking of CAPAs (Corrective and Preventive Actions).
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Formations
- MDSAP – Intertek2021MDSAP – Intertek
- ISO 14971-2019 Risk management - CVO-EUROPE2020ISO 14971-2019 Risk management - CVO-EUROPE