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Nazli D.ND

Nazli D.

Quality Assurance Change Control

EUR 300/Tag
Genève, CH
3-7 Jahre

Durchschnittliche Reaktionszeit: 1h

Über Nazli

  • Französisch

    Muttersprachlich oder zweisprachig

  • Englisch

    Verhandlungssicher

  • Deutsch

    Grundkenntnisse

  • Türkisch

    Muttersprachlich oder zweisprachig

Vor Ort möglich
Genève (bis zu 50 km), Zurich (bis zu 10 km), Bâle (bis zu 10 km)

Projekt- und Berufserfahrung

  • Merck,
    Project Compliance Expert
    Juni 2022 - Februar 2025 (2 Jahre und 8 Monate)
    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
    April 2019 - August 2019 (4 Monate)
    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 Jahre)
    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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Ausbildung und Abschlüsse

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

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