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    Technical Lead - Raleigh, United States - Tekfortune Inc

    Tekfortune Inc
    Tekfortune Inc Raleigh, United States

    2 weeks ago

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    Description


    Tekfortune is a fast-growing consulting firm specialized in permanent, contract & project-based staffing services for world's leading organizations in a broad range of industries.

    In this quickly changing economic landscape, virtual recruiting and remote work are critical for the future of work.

    To support the active project demands and skills gaps, our staffing experts can help you find the best job for you.



    Technical Lead (CSV, Clinical Systems) :: Raleigh, NC (Onsite)

    Contract

    Keywords:
    CSV, Computer System Validation, Clinical Systems, Safety Systems, Infrastructure Qualification, 21 CFR part 11, GAMP 5, ICH, EMEA, MHRA regulations

    Roles and Responsibilities
    Must Have
    We are looking for a pure validation resource with periodic review, audit experience.
    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
    Good to Have (secondary skills)
    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
    Communication
    Immaculate communication and handles multiple clients/ projects
    Works in Consulting capacity
    (1.) To ensure process improvement and compliance, and participate in technical design discussion and to review technical documents (2.) Co-ordination with On-Site Engineers and attending customer calls (3.) Raising risks, issues and escalation to senior management and customer (4.) To create all quality documents, collect metrics data and conducting Audits. To perform Value creation and KM activities. (5.) To create project plans and keep track of schedule for on time delivery as per the defined quality standards

    For more information and other jobs available please contact our recruitment team at To view all the jobs available in the USA and Asia please visit our website at
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