Added: 2025-05-28 15:29.00
Updated: 2025-05-30 03:21.55

Ricerca Urgente! CSV-DI_Consultant...

Salerno , Campania, Italy

Type: n/a

Category: Administration

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Requirements: English
Company: Black Diamond Networks
Region: Salerno , Campania

Location: Naples area Start Date: July 2025 Duration:1-2 months We are seeking a consultant with expertise in CSV-DI torun a detailed gap assessment of all the legacy integrated andstand-alone systems in their GMP production facility. Provide areport/risks assessment on systems to drive prioritization ofinvestments in the facility. QC lab systems are not part of the GAPassessment, since it is closer to a "state of art", so only systemsin the production areas are in scope. The plant only produces oraldosage form products, so no sterile experience needed.Responsibilities: Run a GAP assessment of stand-alone andintegrated systems to: Assess and understand each systems levelof compliance and risk Develop/map out which of the legacysystems can continue to be utilized, need minor changes, etc. andthose that need to be replaced/upgraded. Create a risk assessmentfor systems that cannot be saved, to drive prioritization ofinvestments Write a detailed CSV/DI gap assessment report IdealProfile: 5+ years CSV-DI experience Ideally previous experiencein executing similar assessments Italian language capabilities ispreferred/ a plus, but not required Able to go on-site on request(mostly to acquire documentation of non-integrated/standalonesystems)
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