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    Compliance & Validation SME, Remote
    NTT DATA Services
    Publication date: Dec 22nd
    Job type: Full Time
    Category: All others
    Location: USA
    View all NTT DATA Services jobs

    Req ID: 83774

    At NTT DATA Services, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees are key factors in our company’s growth, market presence and our ability to help our clients stay a step ahead of the competition. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA Services and for the people who work here.

    NTT DATA Services currently seeks a Compliance & Validation SME, Remote to join our team in Plano, Texas (US-TX), United States (US).

    Required Skills
    • 8-10 years of experience with Compliance & Validation with expertise in Computer Systems Validation (CSV)
    • Good understanding of regulatory requirements and industry standards – including 21 CFR Part 11 (Part 11), cGMPs, GDPs, GLPs, and GCPs for computerized system compliance.
    • Must have experience with FDA compliance of ERP (Oracle / SAP) , Integrations, LIMS, Trackwise systems.
    • Extensive experience in Qualifying Infrastructure & Software and has effectively developed & managed IQ/OQ/PQ plans and execution.
    • Experience with Validating Cloud Infrastructure and Cloud Applications is big plus.
    • Collaborate with Delivery teams in ensuring the Deliverables meet the compliance/GDP standards.
    • Good understanding of Life Sciences Domain and processes.

    Preferred Skills

    Preferable experience Validating EDC, eQMS, laboratory instrumentation, and other business information systems.

    Process and Equipment validation experience is desirable.

    This role is going to be at least 50% billable role and remaining time spent on Sales Support, Solution development and building Competency.

    This position is only available to those interested in direct staff employment opportunities with NTT DATA, Inc. or its subsidiaries. Please note, 1099 or corp-2-corp contractors or the equivalent will NOT be considered. We offer a full comprehensive benefits package that starts from your first day of employment.

    About NTT DATA Services

    NTT DATA Services partners with clients to navigate and simplify the modern complexities of business and technology, delivering the insights, solutions and outcomes that matter most. We deliver tangible business results by combining deep industry expertise with applied innovations in digital, cloud and automation across a comprehensive portfolio of consulting, applications, infrastructure and business process services.

    NTT DATA Services, headquartered in Plano, Texas, is a division of NTT DATA Corporation, a top 10 global business and IT services provider with 118,000+ professionals in more than 50 countries, and NTT Group, a partner to 88 percent of the Fortune 100. Visit

    NTT DATA, Inc. (the “Company”) is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. The Company will consider all qualified applicants for employment without regard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, gender identity, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law. To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.

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