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Nazli D.ND

Nazli D.

Quality Assurance Change Control

300 €/jour
Genève, CH
3-7 ans

Délai de réponse moyen : 1h

À propos de Nazli

  • Français

    Bilingue ou natif

  • Anglais

    Capacité professionnelle complète

  • Allemand

    Notions

  • Turc

    Bilingue ou natif

Accepte de travailler sur site
Genève (jusqu’à 50 km), Zurich (jusqu’à 10 km), Bâle (jusqu’à 10 km)

Expériences

  • Merck,
    Project Compliance Expert
    juin 2022 - février 2025 (2 ans et 8 mois)
    Aubonne, VD, Switzerland
    Project lead for Quality and Technical subjects (led cross-functional projects aimed at improving quality processes) Change control (CCP) coach for the Technical and Digital Operation Department
    • 150 persons (Initial and Periodical Qualification, Metrology, Automation, Maintenance, HVAC, Utilities, Digital, Facility Management and Engineering) Provided technical and operational support to TDO department teams to ensure compliance with CCP standards and risk management ((AMDEC, FMECA)) Trained and coached team members on best practices in risk management and CCP processes Acted as the CCP system owner for TDO guarantor, ensuring all processes met regulatory and internal requirements. Pilot and report the KPI Backup Suppliers Management & Qualification Support Inspection and Audit
  • Teisseire -
    Quality & Formulation Technician
    avril 2019 - août 2019 (4 mois)
    I, NE, USA
    Physical-chemical and organoleptic analyses of raw materials (viscosity, density, pH, acidity, spectroscopy)
  • LFBManufacturing,
    Quality Assurance & System Change Control
    mai 2020 - mai 2022 (2 ans)
    Les Ulis, France
    Project lead: Optimization of Change Control flow (creation of a new SOP and WI, redefine the roles and responsibilities, optimization of TrackWise & Revalidation after modification and provide users training ) Supporting the change control from initiation to implementation for 3 sites (Ulis, Lille and Arras). Review of all change controls (technical, process, regulatory, tech transfert, quality and supplier) Pilot and report KPI (CAPA, deviation, change control) Scheduling and lead the change control review board meetings with impacted services Reviewing change controls, SOPs, and other documentation. Participation of the CAPA effectiveness review implementation project

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Formations

  • Master Pharmaceutical Sciences
    University Paris Saclay
    2021
    Master Pharmaceutical Sciences
  • Bachelor's degree Chemistry
    Bachelor's degree Chemistry

Catégories