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    CSV Compliance Specialist - Decatur, United States - LS Solutions Inc

    LS Solutions Inc
    LS Solutions Inc Decatur, United States

    3 weeks ago

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    Description

    Job Title: CSV Compliance Specialist

    Check all associated application documentation thoroughly before clicking on the apply button at the bottom of this description.

    Location: Decatur, Illinois, United States

    Job Type : 6+ months Contract

    JOB DESCRIPTION

    CSV Compliance Specialist

    Our client is a mid-sized pharmaceutical company, who just underwent a large acquisition. They are seeking a highly motivated and experienced CSV Compliance Specialist to validate and revalidate GxP Computerized Systems and on-premises IT infrastructure at a newly acquired facility.

    This individual will be responsible for validating and revalidating the GxP Computerized Systems and on-premises IT infrastructure, and will play a pivotal role in projects, programs, and support work related to Computer System Validation.

    This role reports into the Sr Manager of IT Quality and Validation.

    This person must be capable of validating/ revalidating GxP Computerized Systems located in QC, laboratory, manufacturing, warehouse, engineering, QA, IT departments, and therefore should have relevant experience within these spaces.

    Other requirements include:

    • qualifying/ re-qualifying cloud-based environment IaaS, SaaS, PaaS
    • Review validation deliverables in project initiation phase - User Requirement Specifications (URS) and GxP Assessment, Functional Specifications, Design Specifications, Configuration Specifications, Technical Specifications, etc.
    • Preparing or reviewing validation deliverables in testing phase – Protocols and Test Scripts for Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). Requirement Traceability Matrix (RTM) report, 21 CFR Part 11 Assessment, Summary reports.

    Required Skillset

    The must haves

    • Computer Systems Validation 7+ years
    • Proficient in Technical Writing, MS Office and Adobe documentation software
    • Author, Execution, & Review of CSV SOP's, Templates, Change Controls, Deviation tasks, CAPA tasks
    • Knowledge of Compliance Guidance's related to CSV

    21 CFR Part 11

    EU Vol4 Annex 11

    ISPE GAMP5,

    PIC/s,

    ICHQ9

    • Must have excellent English communication skills (written and spoken)
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