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Mountain View

    CSV Specialist with QMS and life science - Mountain View, United States - Net2source

    Net2source
    Net2source Mountain View, United States

    3 weeks ago

    Default job background
    Description
    Net

    2

    Source Inc.

    is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries.

    We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.

    Role CSV Specialist with QMS and life science
    Location – Mountain View, CA - Onsite

    Hire Type:
    Fulltime - Permanent

    Role Description
    We are seeking a highly skilled and experienced CSV Specialist who will play a crucial role in
    planning and executing the validation of computerized systems which support applications,
    medical devices, and quality management system by ensuring compliance with industry regulations
    and standards. This individual plays a key role in implementation, maintenance, and retirement of
    regulated computerized systems which are considered as non-products.

    Role Responsibilities
    Work with software vendors and internal cross functional teams to ensure systems are
    appropriately validated, implemented, and maintained in accordance with current industry
    practices.
    Provide CAPA, audit, and overall QMS support in regards to eQMS.
    Act as SME for CSV and IT Infrastructure related projects to guide product and IT teams to
    ensure that a consistent approach is utilized in the validation and qualification activities.

    Qualifications:

    4+ years of work experience, preferably in a regulated industry, e.g. medical device,
    pharmaceutical under good clinical, laboratory, manufacturing, and distribution practice
    (GxP) environments.
    Working knowledge of GxP regulations, CSV/CSA principles, including, but not limited to:21 CFR Part 11, Annex 11, GAMP 5, Data Integrity, FDA QSR, ISO 13485, and/or EU
    MDD/MDR, ICH 10.
    Understanding and execution of Computer System Validation practices and processes in
    the life science industry, including validation of SaaS, IaaS, PaaS. Demonstrated ability to
    implement and improve CSV processes using SDLC best practices.
    Skilled in handling end-to-end CSV projects implementation and application of project
    controls, including familiarity with all project lifecycle phases from requirement gathering
    through delivery, issues/risk management, change management, release management.
    Preferred
    Comfortable with Apps for Work applications and experience using SQL and data
    analytics platforms.
    Working knowledge of database management, software test tools, project management
    methodology, change control, quality and system performance methods and metrics

    Regards,
    Prashant Singh
    Sr. Account Manager - Enterprise Business
    Net2Source Inc.
    Direct # | Board #

    Ext


    509 | Fax:
    Office: 270 Davidson Ave, Suite 704, Somerset, NJ 08873

    LinkedIn:

    Website:
    #J-18808-Ljbffr
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