eCompliance Manager

Summary

The eCompliance Manager is responsible for providing Quality Assurance oversight and guidance with regard to computerized systems validation (CSV), operating within the framework of regulations (GxP, 21CFR11, etc.) and requirements defined in the Novartis Quality Manual and global procedures.

eCompliance Manager provides the needed operational support such as approving the GxP impacted changes, Periodic Review Reports, deviations etc., Provides the guidance to the project and operations team on the CSV related topics and related information. Reviews and / or approves the global Computerized Systems key validation deliverables as a part of the eCompliance support to the GxP projects.

About The Role

Major accountabilities :

• 1. Quality oversight of operational activities of GxP systems (e.g., Changes, Periodic Reviews, Deviations etc.,)
• Provide needed support to meet the applicable Novartis and regulatory requirements for GxP regulated computerized systems projects.
• Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture.
• Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems.
• Establish trusted partnership with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support.
• Review and approve the GxP Changes and the associated deliverables.
• Review and approve the GxP impacted deviations, ensure appropriate CAPA are implemented.
• Contribute for the preparation of VMP and execute the plan for the systems associated with the respective functions.
• Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within CAPA Management System.
• Perform supplier qualification assessment activities.
• Provide Audit support as assigned and in case of CAPAs, provide the required Quality support.

Key Performance Indicators

Minimum Requirements

Work Experience :

Skills

Languages

Why Novartis : Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here : https : / / www.novartis.com / about / strategy / people-and-culture

You'll receive : You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https : / / www.novartis.com / careers / benefits-rewards

Commitment To Diversity And Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams&apos representative of the patients and communities we serve.

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Skills Required

Sap, Itsm, Erp, Lims, Iam, Quality Management, Mes, Itil, Crm