Product Steward job in Wilson
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
|State:||North Carolina (NC)|
Owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical variables, ensuring|
processes are robust, in continued state of validation and continuously improving.
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.
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.
Review APQR and decide on state of control.
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.
Assist initiating the product-specific monitoring of all critical In Process Controls (IPC) and release parameters in each laboratory (transfer of the product-specific QRA).
Ensure data and trending are visible and communicated at shop floor level.
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.
Ensure creation of Master Batch Record.
Contribute to registration strategy and support registration activities.
Design and manage optimization projects.
Provide SME expertise to perform process characterization of pharmaceutical processes to increase robustness and sustainability.
Collaborate with OPEX for product / process improvements.BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent
Desirable MSc. or equivalent experience.
Minimum 8 year experience in process support, e.g. Process Expert
role on the shop floor of pharmaceutical manufacturing and/or QA/QC.
Proven process understanding (Pharma, GMP, Regulatory aspects).
Sound experience of data handling and applied statistics is a must.