摘要
Ensures seamless flow of knowledge and information across functions, and with other Sites when applicable, with focus on the assigned product(s). Provides second line technical/scientific process support.
About the Role
Major Accountabilities:
- Maintain the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date, act as SPOC.
- Create and maintain a product specific Quality Risk Analysis (QRAs).
- Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending.
- Ensure inspection readiness for all process related aspects of assigned products.
- Track and evaluate product performance, trending, detect issues, implementation of CAPAs
- Lead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams.
- Responsible for ensuring the continued state of validation (process, cleaning, ongoing verification etc.).
- Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed.
- Design and manage optimization projects.
Essential requirements:
- Degree in Pharmacy, Pharmaceutical Technology, Chemistry, Chemical Engineering or equivalent scientific degree.
- Solid experience in process support, Process Expert role on the shop floor of pharmaceutical manufacturing and/or QA/QC/MS&T.
- Experience of data handling and applied statistics.
- Fluent in English and Italian.
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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