Technical Lead - Raleigh, United States - eTeam

    eTeam
    eTeam Raleigh, United States

    2 weeks ago

    eTeam background
    Description
    CSV, Computer System Validation, Clinical Systems, periodic review and audit experience


    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