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CSV 21 CFR Part 11: Contract - Oferta z Jobs.pl

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CSV 21 CFR Part 11: Contract

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    • Understand and adhere to the Client Regulations/Processes, SOP on Project Management, Change Management, Document Management and Quality Management; and Computerized System Validation concept with regards to document management, and V Model Methodology.
    • Support the Project Manager throughout the project delivery, with regards to aspects of project related risk, compliance and quality.
    • Responsible together with Project Manager for the delivery of all defined Quality Management documentation.
    • Pro-actively seek Project Manager input to develop sharing of necessary QM controls and validation of all QM Documentation.
    • Maintain the project risk register for all ongoing projects, perform root cause analysis on trends and address deviations via preventive, detective and corrective measures to enhance PQM's deliverables and competencies.
    • Establish, implement and monitor the QM requirements which assures that IT Projects meet Quality and Regulatory requirements.
    • Applies required internal and external Quality/Compliance standards to work products (Change control, validation documents etc.)
    • Ensure adequate analysis have been performed for relevant testing conditions based on functional risk assessment, test overview list, test plan, test results, test deviations and change requests.
    • Oversee the validation of the deliverables as per client project management methodology.
    • Train and coach the project team, as required, on relevant project procedures, good documentation practice, good testing practice and CSV basics, where applicable.
    • Manage appropriateness of preparation and readiness of the project for hand-over of the system/processes to the operational organization together with the project managers
    • Perform the project tollgate/check point reviews and post implementation reviews with reporting to management.
    • Participate in compliance audits related to GxP and SoX controls and provide required information related to audit findings, deviation handling, RCA & CAPA.

    Mandatory Skills: GxP, CSV, 21 CFR Part 11
    Good to Have Skills: SOX, SOX IT, Data Privacy, IT Security


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