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    Technical Lead - Raleigh, United States - Katalyst Healthcares and Life Sciences

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

    2 weeks ago

    Default job background
    Description
    Responsibilities:
    • looking for a pure validation resource with periodic review, audit experience.
    • We are 10 + 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.
    • 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 result of Change, Periodic Review, Audits Communication.
    • Immaculate communication and handles multiple clients/ projects
    Requirements:
    • To ensure process improvement and compliance, and participate in technical design discussion and to review technical documents.
    • Co-ordination with On-Site Engineers and attending customer calls.
    • Raising risks, issues and escalation to senior management and customer.
    • To create all quality documents, collect metrics data and conducting Audits. To perform Value creation and KM activities..
    • To create project plans and keep track of schedule for on time delivery as per the defined quality standards
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