CSV Manager (Computer Systems Validation) @ Siera It Services

Job Description

Computer Systems Validation analyst 

    Computer Systems Validation Leader / Manger is responsible for Quality oversight and management of Computer System Validation (CSV) in accordance with industry standards and regulatory guidance. 
    This is a hands-on oversight role that will be accountable for ensuring that Clients computer systems are appropriately validated before release and remain in a compliant state throughout their life. This position requires a broad range of knowledge and a deep understanding of various rules and regulations as well as international standards and guidelines.
    Maintain CSV and Computer System Change Control processes
    Apply risk-based methodologies in the oversight of Computer validation and Instrument System qualification efforts
    Provide leadership and guidance to NTT Data / Client personnel on CSV matters and ensure compliance to applicable industry regulations
    Maintain CSV templates
    Conduct GxP evaluations of new Computer and Instrument Systems
    Work collaboratively across functions with Quality, IT, Business partners, and Vendors to plan, coordinate, and execute CSV activities
    Review CSV lifecycle documentation from a Quality perspective and approve as Quality representative
    Oversee formal test execution to ensure the testing was performed appropriately and the test results are compiled in a timely manner
    Review and approve System-specific Administration and User SOPs
    Oversee the readiness of the CSV program to ensure Computer Systems are compliant and ready for regulatory reviews
     Be the QA CSV Subject Matter Expert (SME) in support of audits and regulatory matters
    Provide guidance and direction throughout the GxP Computer and Instrument System Change Control process
    Ensure appropriate standards and practices are implemented for the collection, use, transfer, storage, and deletion of personal information in GxP Computer and Instrument Systems
    Perform Quality oversight and approval of periodic user access review
    Ensure CSV lifecycle documentation is completed and filed appropriately
    Maintain and present applicable metrics and key performance indicators
    Review of application vendor's qualification and/or validation documentation, as applicable
    Work with vendors for change control management, incident management and issue resolution
    Proactively identify and collate information required to assess compliance with processes and prioritize business process improvement needs.
    Review, assess and update procedural documents for overall compliance with current processes, as required
    Proactively collaborate with initiative leads and senior management to develop, optimize and improve CSV processes, training, and communications
    Perform special projects, assignments, and administrative tasks per business needs
    Provide guidance and review or create varied support materials, presentations, and/or tools to support department's remit and strategies.
    Mentor, coach, and support team members

 Education and Experience

    12+ years of experience working in electronic based Computer System Validation in a GxP environment  
    Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process
    Experience in employing risk-based approaches to CSV
    Experience in qualification of GLP Instrument Systems
    Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems
    Experience in performing validation of cloud-based Computer solutions
    Significant experience in authoring, reviewing and execution of validation and qualification documents, including test scripts.
    Project management experience for regulatory projects
    Knowledge of practices and procedures of the full software development life cycle
    Strong attention to detail
    Hands on experience with eDMS tools like Documentum or Master Control, as well as testing tools like Jira, ALM, etc.
    Bachelor's degree or equivalent and relevant formal academic / vocational qualification or previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
    GAMP, GxP and VLMS/eDMS application training (desirable)

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Keyskills:   alm gxp jira gamp