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    Validation Engineer - Chicago, United States - Colsh Consultants LLC.

    Colsh Consultants LLC.
    Colsh Consultants LLC. Chicago, United States

    2 weeks ago

    Default job background
    Description
    StrongExperience in Computer Systems Validation (CSV) within the Pharmaceuticalindustry.


    • Required Bachelor's degree in pharmaceutical Science OR related field of study.
    • Schedule and plan equipment and process qualification workload to meet approvedschedules.
    • Handle multiple projects and be able to work independently as required.
    • Develop GxP system lifecycle documentation, including Validation Plans, UserRequirements Specifications, Functional Design Specifications, ConfigurationSpecifications, Testing Protocols (IQ/OQ/PQ/VSR/Deviations), User Acceptancetesting, Traceability matrix, System and Validation reports, SOPs, ChangeControl Documentation, and Risk assessment/FMEA reports as required.
    • Establish critical parameters, plan, design, and implement validation projectsand protocols.
    • Ability to author, execute, and thoroughly review complex protocols anddocumentation.
    • Coordinate validation activities with other departments.
    • Stay current with industry qualification trends through FDA, ISPE, EU and benchmarked companies.
    • Consult, coordinate, cross-function with various personnel within the companyand externally.
    • Have the ability to problem solve with minimal oversight, including conductingresearch to aid in the resolution of issues that arise.
    • Train and mentor other Validation personnel as necessary.
    • Determine and acquire necessary supplies and equipment for validationactivities (Planning).
    • Administer the site Change Control/Management Program.
    • Make decisions representing QA in multi-functional teams.
    • Plan and assist with the Global serialization project (as necessary).
    • Familiarity and experience with TrackWise, LIMS, ComplianceWire, JDE, GAMP isdesirable
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    Consulting Services

    We extend our services to wide range of businesses by empowering them to maximize their business growth revenue. We aim to offer diversified services to the clients Read more
    Products and Solutions

    We extend our services to wide range of businesses by empowering them to maximize their business growth revenue. We aim to offer diversified services to the clients Read more
    Corporate Training

    We extend our services to wide range of businesses by empowering them to maximize their business growth revenue. We aim to offer diversified services to the clients Read more
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    We extend our services to wide range of businesses by empowering them to maximize their business growth revenue. We aim to offer diversified services to the clients Read more

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