Requirements: English
Company: JR Italy
Region: Cuneo , Piedmont
Social network you want to login/join with:Job Description: CSV-DI ConsultantWe are seeking a consultant with expertise in CSV-DI to conduct a detailed gap assessment of all legacy integrated and stand-alone systems within our GMP production facility. The consultant will provide a comprehensive report and risk assessment to guide investment prioritization in the facility. Note that QC lab systems are excluded from this assessment, as they are considered to be closer to a ''state of the art'' level. The scope is limited to systems in the production areas, which exclusively produce oral dosage form products; sterile experience is not required.Responsibilities:Conduct a GAP assessment of stand-alone and integrated systems to:Assess and understand each systems compliance level and associated risksDetermine which legacy systems can be retained, require minor modifications, or need replacement/upgradingCreate a risk assessment for systems that cannot be preserved to aid in prioritization of investmentsWrite a detailed CSV/DI gap assessment reportIdeal Profile:Minimum of 5+ years of CSV-DI experiencePrevious experience in similar assessments is preferredItalian language skills are a plus but not mandatoryAvailability to visit the site as needed, primarily to gather documentation of non-integrated/standalone systems#J-18808-Ljbffr