Sr Qa Validation Specialist - Limerick - Regeneron Ireland DAC

    Regeneron Ireland DAC
    Regeneron Ireland DAC Limerick

    6 hours ago

    Default job background
    Full time
    Description

    Job Summary

    The Sr QA Validation Specialist (IT Infrastructure) implements policies and procedures to qualify IT infrastructure platforms and validate computer systems. They plan, coordinate, and participate in a compliant qualification process for qualifying information technology infrastructure platforms which requires formal qualification documentation under appropriate regulatory requirements and company standards.

    Key Responsibilities:

    • Analysing the results of testing and determines the acceptability of results against predetermined criteria
    • Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements
    • Identifying current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation vital to ensure compliance within the operation
    • Leading process improvement projects to improve the qualification of infrastructure platforms
    • Coordinating with other departments or outside contractors/vendors to complete validation tasks
    • Participating in regulatory audits and communicates company's computer validation policies
    • Assessing company's infrastructure platforms and identifies any potential security gaps and ensure the best data integrity practices are implemented
    • Training Specialists and Technicians
    • Technical writing experience Generating, reviewing, and approving of qualification/validation documents
    • Completing risk assessments in relation to IT infrastructure activities
    • Advising and supporting all teams on IT infrastructure and computer systems qualification activities

    Requirements:

    • Experience with principles of infrastructure and VMware in the Private & Hybrid Cloud domain, as well as an understanding of network infrastructure devices, firewalls and active directory administration
    • Solid understanding and experience with Computer Systems Validation and/or IT Auditing
    • Understanding of the interdependencies of change management, deviation and continuous improvement
    • Able to work in a dynamic organization where innovative solutions are required to ensure a high-level of quality is achieved within required timelines
    • Thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7 A, FDA parts 210 and 211
    • Bachelor's degree in Computer Science, Information Systems, or a related field with at least 5+ years of experience in IT CSV engineering or a related field
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