Validation Lead - Remote

  • Warszawa, mazowieckie
  • Specjalista
  • 90–125 zł brutto / godz.
  • Praca zdalna
  • Umowa o pracę, Kontrakt B2B
  • Pełny etat
  • 22.08.2019
  • Ważna jeszcze 0 dni (do 21.09.2019)

    Pracodawca ma prawo zakończyć rekrutację we wcześniejszym terminie.

    ASTEK Poland is a rapidly growing local branch of the international ASTEK Group. We specialize in IT staff outsourcing and in the implementation of IT projects. We employ experienced specialists for the leaders of banking, insurance, telecommunications, high-tech, pharmacy, logistics in Poland and abroad.
    Validation Lead - Remote
    Location: Warszawa

    Responsibilities:

    • Provide estimates and forecasting for CSV project resource needs
    • Leading and assist project team in the development and approval of computerized systems requirements in accordance with guidance and policy document
    • Autor validation plans/report reviews test plans/report, summary reports notifying that system is ready to go life. Coordinates all validation activities on a global level/organizational level for system/project or participates actively in validation discussion, provide consultancy for all validation related questions
    • Lead and author system and functional risk assessments
    • Manages defect resolution and testing deviations
    • Ensures code release procedures are adhered to and software is appropriately versioned and maintained
    • Develop/audit new processes and process improvement initiatives. Revise SOP's/other documentation as applicable. Liaison with business quality/informatics quality to ensure compliance with corporate quality policies and standards
    • Implementation and utilization of governance processes and participating in planning system deployment process
    • Observes governance processes, escalates area for improvement and assists in the implementation and monitoring of solutions
    • Supports audit teams as CSV Subject Matter Expert, supporta audit/inspection preparation, management and run
    • Presents validation status/ strategy for audit/inspection purposes
    • Supports system maintenance with validated state and permanent audit readiness
    • Implements relevant framework and process, uses tools and follows SOP's end-to-end
    • Maintains appropriate documentation of tasks, incidents and activities performed
    • Develop validation documentation as required and is accountable for entire validation documentation
    • Review and approve documents prepared by the team, other functional departments and contractors
    • Initiate and implement change control activities.
    • Coordinate re-validation
    • Providing training and validation/quality knowledge/experience exchange support
    • Strategic/essential oversight over validation support within department and providing support /consultancy for the team and within global organization if necessary

    Requirements:

    • Experience leading validation in projects and system maintenance in various areas
    • Experience authoring or reviewing test/validation plans, system design documents
    • Experience with project management, CSV Software
    • Development lifecycle models in pharmaceutical industry or related
    • Experience in the quality maintenance and support of regulated applications
    • Experience with maintenance and support of applications under global inspection agencies, CFR 21, FDA Part 11
    • English at least at C2 level

    We offer:

    • attractive salary
    • stable employment and professional development opportunities in an international environment
    • possibility of choosing preferred type of contract
    • working for well-known Polish and global brands
    • trainings
    • interesting, long-term projects
    • employee benefits package (private medical care, Multisport card), nice work atmosphere and team-building meetings
    • constant support of dedicated Astek Polska manager
    • cooperation with specialists in a given field
    If you are interested in our offer, please send your application via "Aplikuj teraz" button.
    Please be informed that we shall contact only selected candidates.
    We inform that the personal data Administrator is ASTEK Polska Sp. z o.o. ul. Mokotowska 1, 00-640 Warszawa. The purpose of collecting and storing personal data is to conduct recruitment processes by ASTEK Polska sp. z o.o. You have the right to access and amend your data. Data submission is voluntary.
    Why you should work with us?
    Solid Foundations
    Ambitious Projects
    Individual approach and friendly atmosphere
    Famous Brands
    Inspiring Leaders
    Flexibility
    Extra Benefits
    Referral System
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