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.
- 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.
- Present product performance and status of product improvement projects in site Manufacturing Robustness Review Board (MRRB).
- Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed.
- 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.
- Provide SME expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability.
Essential requirements:
- Scientific Degree.
- Previous experience in a similar role within manufacturing/quality/MS&T department of a pharmaceutical/biotech company.
- Strong technical knowledge.
- Fluent in Italian and English.
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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