CSV-DI_Consultant

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)