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    CSV Consultant - Raleigh, United States - Katalyst Healthcares & Life Sciences

    Katalyst Healthcares & Life Sciences
    Katalyst Healthcares & Life Sciences Raleigh, United States

    3 weeks ago

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    Description

    Responsibilities:

    • We are looking for a pure validation resource with periodic review, audit experience.
    • years' Experience in Validating GxP applications
    • Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy.
    • Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory quality.
    • Support Risk assessment.
    • Document Regulatory Requirements and Review Specification documentation (viz. User Stories, URS, FRS)
    • Review and final Approval of requirements, Technical Design and Solution Architecture Plan, IQ, OQ and PQ pre and post execution documents.
    • Lead, Write, Review/ Approve Discrepancy Logs (final dispositions)
    • Lead, Write, Review / Approve Requirement Traceability Matrix (RTM) and Validation Summary Reports

    Requirements:

    • Experience in Clinical systems like CTMS, CDMS, EDC, Veeva Vault, QMS and Safety Systems and Infrastructure Qualification
    • Conduct Periodic Reviews of GxP Apps as per the frequency stated in the governing SOP and write Periodic review reports and Review and Approve Periodic Review Reports
    • Tracks the Periodic review findings and open CAPA s to a closure.
    • Review and Approve System Support and Operations plan.
    • Participate in and support Audits.
    • Contribute and Review/ Approve Decommissioning Plans & Decommissioning Reports
    • Contribute, Review/ Approve deliverables for Change Management Support
    • Maintain validation documentation throughout product lifecycle a result of Change, Periodic Review, Audits
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