Location: Naples area
Start Date: July 2025
Duration: 1-2 months
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 risk
Develop/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 investments
Write a detailed CSV/DI gap assessment report
Ideal Profile:
5+ years CSV-DI experience
Ideally previous experience in executing similar assessments
Italian language capabilities is preferred/ a plus, but not required
Able to go on-site on request (mostly to acquire documentation of non-integrated/standalone systems)