Requirements: English
Company: JR Italy
Region: Rovigo , Veneto
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 in our GMP production facility. The assessment will include a comprehensive report and risk analysis to prioritize investments 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 plant exclusively produces oral dosage form products; therefore, 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 continue to be used, require minor modifications, or need replacement/upgradingCreate a risk assessment for systems that cannot be retained, to inform investment prioritizationPrepare a detailed CSV/DI gap assessment reportIdeal Profile:Minimum of 5+ years of CSV-DI experiencePrevious experience in executing similar assessments is preferredItalian language skills are a plus but not mandatoryWillingness and ability to visit the site as needed, primarily to gather documentation of non-integrated/standalone systems#J-18808-Ljbffr