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    IT Business Analyst/ Application Engineer - Oklahoma City, United States - uniQure

    uniQure
    uniQure Oklahoma City, United States

    2 weeks ago

    Default job background
    Description

    Location:
    Lexington, 113 Hartwell Ave Education level: Bachelor / Graduate

    Job category:
    Information Technology corporate Target start date: 1/22/2024

    Work Location:
    On-
    Site Shift: 1st

    uniQure is dedicated to bring innovative therapies or unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients.

    This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

    Role & Place in the Organization


    Part of the Global IT team, the IT Business Analyst / Application Engineer of GxP Systems is an on-site all-around IT Professional, responsible for the implementation and support of IT enterprise quality systems and laboratory computer systems.

    You are also responsible for the IT compliance to GxP regulations. You work with all business stakeholders, auditors, and IT partners to ensure the right solutions are delivered.

    Key Result Areas (major Duties, Accountabilities And Responsibilities)

    IT GxP
    Executes risk-based strategy for Computer System Validation (CSV) lifecycle, including implementation, validation, maintenance.
    Represents IT in collaboration with QA and other stakeholders (MFG, QC, R&D) to determine validation requirements.
    Executes Computer System Validation SOPs, protocols, and templates.
    Ensures that the IT environment of uniQure is compliant to relevant quality standards.
    Participates and provide artifacts and evidence per internal and external quality audits.
    IT Projects
    Gather and analyzes the requirements for the IT systems used for Enterprise Quality Management, GMP, GLP, and overall GxP applications
    Responsible for execution of IT GxP SOP
    IT Application Management per IT GxP SOP
    Supports selected Key Business applications
    User Access management per 21 CFR Part 11
    Ensures Backup and Restore process
    Controlled Change and Patch Management

    Qualifications & Skills

    BS or equivalent grade in Computer Sciences
    A minimum of 3 years of working experience as IT professional
    A minimum of 3 years of experience in Life Sciences

    Core competencies

    Excellent communication skills with the ability to interact with junior and senior members of the company
    Reliable, consistent, and proactive
    Ability to address multiple projects and adapt to changing priorities
    Team-oriented and generous in sharing knowledge and enabling others
    Self-motivated and passionate to learn and adopt new technology and methodologies
    Customer Service oriented with attention to detail and quality
    Strong technical background from within the IT industry with exposure to a wide range of (new) technologies
    Experience in resolving multi-disciplinary or multifunctional/process problems
    Ability to manage own workload
    Capable of day-to-day problem solving and taking responsibility for decisions
    Proficient in English, both oral and written

    #J-18808-Ljbffr
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