Product Expert

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b7tfx

ppThe 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. /ph3Major Accountabilities /h3ulliMaintain 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. /liliCreate and maintain a product specific Quality Risk Analysis (QRAs). /liliMonitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending. /liliEnsure inspection readiness for all process related aspects of assigned products. /liliTrack and evaluate product performance, trending, detect issues,



implementation of CAPAs. /liliLead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams. /liliResponsible for ensuring the continued state of validation (process, cleaning, ongoing verification etc.). /liliProvide 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. /liliDesign and manage optimization projects. /li /ulh3Essential requirements /h3ulliDegree in Pharmacy, Pharmaceutical Technology, Chemistry, Chemical Engineering or equivalent scientific degree. /lili6-8 years of experience in Process Support/Process Expert roles within the MST department of a pharmaceutical company. /liliExtensive knowledge of GMP and analytical methods validation. /liliExperience of data handling and applied statistics. /liliFluent in English and Italian. /li /ul /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b7tfx