Summary
About the Role
Your responsibilities include, but are not limited to:
• As being an expert in the system configuration of key applications (e.g. Labware LIMS), conduct gap assessment and define system design and configuration to improve end user satisfaction.
• Create and manage system configuration static master data in key applications. Drive standardization and normalization of global/organization/site static master data.
• Liaise with system and process owners and actively contribute and participate in the system governance and change advisory board.
• Assess risk, conduct RCA and perform impact assessments for changes and problems; As project development lead (workstream lead), own and drive change to key applications in close collaboration with line functions and IT.
• Establish and own URS and be responsible for informal and formal testing and validation UAT / OQ / PQ. Ensure adherence to standards and compliance of processes with regulations as well as Novartis internal procedures and GxP requirements.
• Understand the supported business processes and interfaces of key applications. Identify, align & facilitate global harmonization opportunities across TRD. Collaborate with business process experts to understand, challenge, and incorporate business processes into key applications.
• Contribute to the life-cycle management of key applications. Facilitate the collaboration between Dev IT and Line Functions and external partners for system/application improvement and enhancement projects
• As a subject matter expert or recognized technical expert, provide guidance, training and education to users, super users and team members on usage and best practices in key applications. Act as mentor or coach for junior and senior associates.
Role Requirements :
• Knowledge in quality principles driving drug development such as GMP; understanding of general regulatory and quality expectations.
• Strong communication skills, including presentation and scientific/ technical writing. Advanced coaching skills.
• Minimum 3 years in relevant position in a GMP environment. Sound technical and regulatory knowledge. Working knowledge in pharmaceutical research and technical development.
• Experienced in GMP environment, with familiarity of IT systems (e.g. Labware LIMS, Chromeleon, SAP), and interfaces between different data tools.
• Comprehensive knowledge about project management, excellent organization and planning skills. Experience in upgrading existing IT tools into the mobile IT world (smart phones, tablets).
• Proven track record in successfully leading and working in interdisciplinary teams. Strong innovation mindset and problem solving skills
• Technician or Bachelor/Master in Life Science or Information technology (e.g., analytical / organic chemistry / pharmacy / pharmaceutical development, IT) or equivalent.
• Advanced degree in science of relevant discipline (Ph.D., MSc or equivalent). Familiar with existing IT tools (e.g. Labware LIMS, Chromeleon, SAP) and strong interest in new digital tools.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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