• Validation Engineer

    Job Locations IN-Mumbai
    Posted Date 1 month ago(7/16/2018 1:22 PM)
    Job ID
    2018-1283
    Organization
    Services
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    The Opportunity:

    The Validation Engineer role requires a combination of analytical, communication (written and verbal) and interpersonal skills to be successful. Candidate will work closely with a cross-functional team including Product Managers, Software Developers, and QA Automation Engineers. The target candidate will have validation, QA or testing experience with web applications, as well as familiarity with Microsoft office applications. Knowledge of FDA 21 CRF Part 11 and GAMP5 regulations is also a very strong plus.

     

     

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    Responsibilities include, but are not limited to:

    • Synthesize information from requirements specification documents, user stories, and acceptance criteria
    • Author, review, and execute test cases based on requirements, stories, and AC
    • Author and review validation documents, such as Validation Plans, Traceability Matrices, Validation Summary Reports, Functional Risk Assessments
    • Review automated test results and provide guidance for test improvement
    • Participate in customer meetings as a SME for our validation offering
    • Create and setup test scenarios and test data as needed
    • Work with various teams to promote QA processes, practices and standardization

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    Qualifications:

    • Bachelors in Computer Science, Computer Information Systems, Information Technology, Engineering, or related discipline.
    • Experience testing web-based enterprise-class business applications
    • Experience Authoring and reviewing Validation documents, such as Validation Plans, Traceability Matrices, Validation Summary Reports, Functional Risk Assessments
    • Team mindset with demonstrated enthusiasm and ability to work in highly cross-functional, globally diverse organizations
    • Good time management and organization skills, ability to work independently
    • Experience with MS Office suite
    • Effective written and oral communication skills
    • Ability to work in a fast-paced, dynamic environment; enthusiastic team-player
    • Experience in the pharmaceutical industry preferred
    • Knowledge of FDA regulatory requirements, 21 CFR part 11, and GAMP5 a plus

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