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)