User Support Specialist (CSV, GxP)

We are looking for

User Support Specialist (CSV, GxP)

DK/US/WAW/02

Gdańsk

  • For pharmaceutical company, we’re looking for User Support Specialist with GxP, CSV and ITIL knowledge. As an User Support Specialist, you will be implementing, troubleshoot and maintain service quality for selected applications to support client’s development and manufacturing processes. It is an exciting opportunity to join newly establishing Application Management unit within a dynamic, fast moving environment.

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    Responsibilities

    • Providing IT support and maintenance for laboratory, manufacturing and other supporting business functions systems (e.g. LIMS, Empower, SAP, BOX, QMS)
    • Incidents handling, logging and reporting on application problems
    • Handle standard Service Requests and perform User Administration for various applications
    • Ensuring compliance of a GxP applications operation and maintenance during its operational life cycle
    • Providing user support and guidance to customers through consulting, teaching and publication of documentation for supported applications
    • Monitoring systems and participation in proactive management of its IT infrastructure
    • Support for problem resolutions by close collaboration with the next level support or external Vendors
    • Support of test, Computer System Validation and roll-out activities within planned application changes and maintain relevant documentation (SOP’s, OSP) based on the application/business expertise
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    Skills & Qualifications

    • Experience in application support organization, preferably in the pharmaceutical industry
    • Knowledge/understanding of supported business domain
    • Knowledge of CSV, Data integrity and compliance to 21CFR Part 11 and GxP standards
    • Experience in Citrix environment, TCP/IP implementation, MS Windows/Network
    • Experience working with ITSM processes and tool (Service Now preferably)
    • Strong written and verbal communication skills – ability to visually describe structure or explain a problem
    • Ability to set and maintain priorities for multiple tasks and work under pressure
    • Teamwork spirit – work and support others towards a common goal
    • Language skills – Polish (native or fluent), English (professional level)
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    Your benefits

    • Ongoing development of professional qualifications
    • Stable employment and professional work environment
    • Diversified range of implemented projects
    • Genuine influence on career management
    • Team that respects your opinion
    • Private healthcare and sport packages
    • Team-building activities and sports events