Requirements: English
Company: Black Diamond Networks
Region: Sassari , Sardegna
Location : Naples areaStart Date : July 2025Duration : 1-2 monthsWe are seeking a consultant with expertise in CSV-DI to run a detailed gap assessment of all the legacy integrated and stand-alone systems in their GMP production facility. The assessment will include providing a report and risk analysis to prioritize investments in the facility. Note that QC lab systems are not part of the scope, as they are considered to be closer to a ''state of the art''. 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 associated risksDetermine which legacy systems can continue to be used, require minor modifications, or need replacement/upgradesCreate a risk assessment for systems that cannot be preserved to inform investment prioritiesPrepare a detailed CSV / DI gap assessment report.Ideal Profile :5+ years of CSV-DI experiencePrevious experience in similar assessments is preferredItalian language skills are a plus but not mandatoryWillingness to go on-site as needed, mainly to gather documentation for non-integrated or standalone systems#J-18808-Ljbffr