Requirements: English
Company: JR Italy
Region: Perugia , Umbria
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 a GMP production facility. The assessment aims to provide a report and risk analysis to guide investment prioritization within 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 produces only oral dosage form products, so 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 risksDetermine which legacy systems can be retained, require minor modifications, or need to be replaced/upgradedCreate a risk assessment for systems that cannot be preserved to inform investment decisionsPrepare a comprehensive CSV/DI gap assessment reportIdeal Profile:Minimum 5 years of experience in CSV-DIPrevious experience in similar assessments is preferredItalian language skills are a plus but not mandatoryWillingness to travel on-site as needed, primarily to gather documentation of non-integrated/standalone systems#J-18808-Ljbffr