Requirements: English
Company: JR Italy
Region: Caserta , Campania
Social network you want to login/join with:Job Description: CSV-DI ConsultantWe are seeking a consultant with expertise in CSV-DI to conduct a detailed gap assessment of all legacy integrated and stand-alone systems in our GMP production facility. The assessment will produce a report and risk analysis to prioritize investments in the facility. Please note that QC lab systems are excluded from this assessment, as they are considered to be closer to a ''state of the art''. The scope includes only systems in the production areas. The plant produces oral dosage form products; therefore, sterile experience is not required.Responsibilities:Conduct a GAP assessment of stand-alone and integrated systems to:Assess and understand each systems level of compliance and associated risks.Determine which legacy systems can continue to be used, require minor modifications, or need to be replaced/upgraded.Create a risk assessment for systems that cannot be maintained, to guide investment prioritization.Write a comprehensive CSV/DI gap assessment report.Ideal Profile:Minimum 5+ years of CSV-DI experience.Previous experience in similar assessments is preferred.Italian language skills are a plus, but not mandatory.Willingness to go onsite as needed, primarily to gather documentation of non-integrated/standalone systems.#J-18808-Ljbffr