Product Expert

Job description

Job Description Summary The Product Expert (or Product Steward) 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 process(es) 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. Job Description: 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 / suppo...