System Manager Clearance - Zaventem, België - Next-Link

    Next-Link
    Next-Link Zaventem, België

    2 weken geleden

    Default job background
    Beschrijving

    Job Description:

    • Support the system lead in the following tasks:
    • Project Manager and Communication lead for Source Clear (GxP validated system):
    o Coordinate and collaborate with relevant functional teams to ensure sustainability and enhancement of the system:
    § Core Team – IT/Support/Business process owner
    § Validation
    § Veeva Customer Success Manager
    § Focus group
    § All Country Leads
    § IT services transition

    o Preparation of presentations, Communications and Executive Summaries disseminated to Country Leads/Business Admins/Librarians (all affiliates)

    o Maintain Source clear business governance guidance and other key documentation such as Access Management Associated Instructions, Training Matrix, training content.

    Proactively identify any needs for updates as well as informing the Source clear community and posting Newsflash and Tip's on the Clearance collaboration site
    o Participate in content roadmap activities for technologies improvement


    • Source Clear Change Request Manager, which includes the following activities:
    o Manage Source Clear Change Requests (CRQ) - release activities (4 to 5 per year):
    § Investigate Collect and keep up to date CRQ list and investigations
    § Build CRQ release planning & tasks (release cycle of 8 weeks) in accordance with GxP validated procedure
    § Update documentation in source Controlled docs (URS, TMX...)
    § Manage business PQs (Protocol Qualifications) in QALM system
    § Organize system testing as per validation requirements
    § Release communication to users
    o Veeva release activities
    § Analyze the auto-on enhancements versus configurable changes and their impacts
    § Update controlled documentation:
    Functional Risk Assessment (FRA)
    § Elaborate, validate with core team and finally release communication to users


    • Be fully familiar with process, practical guidance and system training for clearance of product/disease promotional/educational/press material and comply with GCC SOP and validation requirements
    • Support GCC with audits and inspections as required

    Requirements



    • Experience with Veeva Vault PromoMats – configurations, updates, system enhancements
    • Knowledge of GxP
    • Project management experience