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CSV Engineer

Company: Discover International
Location: Cambridge
Posted on: May 11, 2022

Job Description:

CSV Engineer --- 6-month contract - Onsite position Job Summary Maintain project plan, timelines, coordination, and resource management Write, review, and approve GxP computer validation and 21 CFR Part 11 related documentation for eQMS/ERP systems such as risk assessment, validation plan, URS, CS/DS, IQ/OQ/PQ, RTM, and summary report Execute test protocols and test scripts for eQMS/ERP systems Write and provide support for all CSV related deviations, discrepancies and change control documentation Create data maps for multisystem interfaces and integrations and identification of potential data integrity risks Provide project oversight and management for implementation, integration, and validation of eQMS platform Follow GAMP methodologies with compliance to FDA regulations and ISO standards for implementation and validation of integrated eQMS system Document lifecycle management updates and revisions (data migration, archival and retirement of existing application as applicable) Perform SOPs review and revision as applicable (including business continuity plan, disaster recovery plan, IT periodic review, user access review, audit trial review, records and retention, backup, and recovery) Develop SOPs as needed

Keywords: Discover International, Cambridge , CSV Engineer, Engineering , Cambridge, Massachusetts

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