Yulia Zhukova

Computer System Validation Manager at Syncwork Ag
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Contact Information
us****@****om
(386) 825-5501
Location
Berlin Metropolitan Area, DE
Languages
  • Russian Native or bilingual proficiency
  • English Professional working proficiency
  • German Professional working proficiency
  • Spanish Elementary proficiency
Skills

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Credentials

  • ISTQB Certified Tester Foundation Level
    German Testing Board e.V.
    Dec, 2018
    - Oct, 2024
  • Goethe Zertifikat C2 Grosses Deutsches Sprachdiplom
    Goethe-Institut e.V.
    Jun, 2018
    - Oct, 2024
  • Certified Professional for Requirements Engineering Foundation Level
    IREB GmbH
    May, 2018
    - Oct, 2024
  • Qualitätsmanager
    TUV Nord
    Nov, 2017
    - Oct, 2024
  • Qualitätsbeauftragter
    TUV Nord
    Sep, 2017
    - Oct, 2024

Experience

  • Syncwork Ag
    • Germany
    • IT Services and IT Consulting
    • 1 - 100 Employee
    • Computer System Validation Manager
      • May 2018 - Present

       Lead the validation activities in IT projects in pharmaceutical and life science industries. Establish and maintain strong relationships with cross functional departments including Information Technology, Product Supply, Clinical Data Management and Regulatory groups. Draft and review GxP documentation including validation documentation, SOPs, and training documentation. Support testing activities. Review of vendor protocols and creation or approval of in-house protocols…  Lead the validation activities in IT projects in pharmaceutical and life science industries. Establish and maintain strong relationships with cross functional departments including Information Technology, Product Supply, Clinical Data Management and Regulatory groups. Draft and review GxP documentation including validation documentation, SOPs, and training documentation. Support testing activities. Review of vendor protocols and creation or approval of in-house protocols and reports to deliver a complete package of validation documentation. As a key member of the Quality team, contribute to the overall validation strategy as well as act as a point of contact for internal and external stakeholders. Train team members in procedures relating to validation as required. Participate in and respond to inspections by Regulatory Authorities including MHRA and FDA, representing the validation function. Show more Show less

  • Max Planck Institute of Colloids and Interfaces
    • Germany
    • Research Services
    • 100 - 200 Employee
    • PhD Candidate
      • Feb 2014 - Aug 2017

      Thesis title: "Surface nanostructuring for cell and tissue growth"In my PhD project, I studied the interaction of cells with nanostructure titanium surfaces. The goal was to firstly investigate a novel method of creating nanostructure surfaces on titanium, which involved synthesis, materials characterisation followed by a characterisation of the behaviour of bone producing cells on these surfaces. It is hoped that the knowledge gained will assist in the design of better implants for… Thesis title: "Surface nanostructuring for cell and tissue growth"In my PhD project, I studied the interaction of cells with nanostructure titanium surfaces. The goal was to firstly investigate a novel method of creating nanostructure surfaces on titanium, which involved synthesis, materials characterisation followed by a characterisation of the behaviour of bone producing cells on these surfaces. It is hoped that the knowledge gained will assist in the design of better implants for tissue engineering. Apart of hands-on experience, my work-related responsibilities were:-lab management: responsible for correct maintenance of technical equipment, purchase ofchemicals and other consumables;-extensive experience in reading of academic and technical literature;-hiring, training, and management of Masters student for a Joint Research project;-regular report writing and organization of group and mentoring committee meetings;-posters preparation for internal institute meetings.Expected completion date: August, 2017 Show more Show less

  • Russian State University named after Immanuel Kant (former Kaliningrad State University)
    • Russian Federation
    • IT Services and IT Consulting
    • Engineer
      • Jan 2011 - Oct 2011

      Medical Biotechnology

Education

  • Max Planck Institute of Colloids and Interfaces
    -
  • Freie Universität Berlin
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  • Humboldt-Universität zu Berlin
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  • Kaliningrad State Technical University
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  • Ganzejskaja Ladja Secondary School
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