We 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. Provide a report / risks assessment on systems to drive prioritization of investments in the facility. QC lab systems are not part of the GAP assessment, since it is closer to a "state of art", so only systems in the production areas are in scope. The plant only produces oral dosage form products, so no sterile experience needed.Responsibilities :Run a GAP assessment of stand-alone and integrated systems to :Assess and understand each systems’ level of compliance and riskDevelop / map out which of the legacy systems can continue to be utilized, need minor changes, etc. and those that need to be replaced / upgraded.Create a risk assessment for systems that cannot be saved, to drive prioritization of investmentsWrite a detailed CSV / DI gap assessment reportIdeal Profile :5+ years CSV-DI experienceIdeally previous experience in executing similar assessmentsItalian language capabilities is preferred / a plus, but not requiredAble to go on-site on request (mostly to acquire documentation of non-integrated / standalone systems)
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