Job Description

Sr. eCompliance Specialist Location - Hyderabad #LI Hybrid About the Role: Supports effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators). -Supports the preparation and management of external and corporate audits and Health Authority inspections. Key Responsibilities: . The eCompliance Sr. Specialist 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. . 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 Global Computerized Systems and act as an interface between TT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture. . Review and approve project related documents for Global GxP relevant systems including determination of GxP applicability for all Global GxP and non-GxP relevant systems. . Establish trusted partnership with assigned TT Function with understanding of business drivers, and provide the needed day to day operational support. 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 validated CAPA management tool. . Provide audit support as assigned and in case of CAPAs, provides the required Quality support. . Ensure that TT relevant vendors are adequately assessed according to the Novartis strategy and requirements support the execution of vendor qualification activities, as appropriate Diversity & Inclusion / EEO Minimum Requirements Essential Requirements: . 6-10 years of overall experience, and a minimum 5 years of relevant experience in the Pharmaceutical Industry within particular in regulated functions such as IT Quality and Compliance. . Good understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.) . Good experience in the development, implementation and lifecycle management of computerized systems in regulated environments . Experienced in the operational management of GxP solutions including its related technologies to support the operation. Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.) . Experienced in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space . Successful cross-divisional/functional work with complex international teams. Ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude . Self-starter with experience in initiating and delivering projects and processes. Excellent communication, negotiation, facilitation, and interpersonal skills Desirable Requirements: . College/university degree, preferably in security, criminal justice, crisis management, business continuity or other related field. Advanced degree is highly desirable (e.g., Master\'s degree or MBA). 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: You\'ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: .

foundit