Requirements: English
Company: JR Italy
Region: Monza , Lombardy
Social network you want to login/join with:Job Description: CSV-DI Systems ConsultantWe are seeking a consultant with expertise in CSV-DI to conduct a detailed gap assessment of all legacy integrated and stand-alone systems in our GMP production facility. The consultant will provide a report and risk assessment on these systems to prioritize investment decisions. Please note that QC lab systems are excluded from this assessment, as they are considered to be near the ''state of the art''. The scope is limited to systems in the production areas of the plant, which exclusively produces oral dosage forms; sterile experience is not required.Responsibilities:Perform a GAP assessment of stand-alone and integrated systems, focusing on:Assessing and understanding each systems compliance level and associated risksMapping out which legacy systems can continue to be used, require minor modifications, or need replacement/upgradesCreating risk assessments for systems that cannot be preserved, to inform investment prioritizationPreparing a comprehensive CSV/DI gap assessment reportIdeal Profile:Minimum 5 years of experience in CSV-DIPrevious experience in conducting similar assessments is preferredProficiency in Italian is a plus but not mandatoryAvailability to visit onsite as needed, primarily to obtain documentation of non-integrated and standalone systems#J-18808-Ljbffr