Requirements: English
Company: JR Italy
Region: Teramo , Abruzzo
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 consultant will provide a report and risk assessment to prioritize investments in the facility. Please note that QC lab systems are excluded from this assessment, as they are considered to be closer to a "state of the art" standard. The scope is limited to systems in the production areas; 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 level of compliance and associated risksDetermine which legacy systems can continue to be used, require minor modifications, or need to be replaced/upgradedCreate a risk assessment for systems that cannot be maintained, to guide investment prioritizationPrepare a detailed 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 mandatoryAvailability to visit the site as needed, primarily to gather documentation of non-integrated/standalone systems#J-18808-Ljbffr