Junior Computer System Validation, Milan Milano

Junior Computer System Validation, Milan
Milano
Lombardia, Milano

Social network you want to login/join with:Client:EurofinsLocation:Vimodrone (MI)Job Category:OtherEU work permit required:YesJob Reference:019be842dd1cJob Views:27Posted:22. 01. 2025Expiry Date:08. 03. 2025Job Description:Eurofins BioPharma Product Testing (BPT) is looking for a Junior Computer System Validation professional who will collaborate with the European CSV Coordinator to assure the GMP compliance required for all computerized systems in use at Eurofins European Biopharma Product Testing. Responsibilities:Support validation activities;Collaborate on the evaluation of changes to computerized systems from a regulatory and data integrity perspective;Assist in the investigation and resolution of compliance issues (Deviation and CAPA);Verify if a computerized system is designed according to applicable regulatory and data integrity requirements: review User Requirements and Software Specifications;Assist in delivering Computerized Systems validation documents;Help ensure that systems are maintained in validated status throughout their lifecycle, keeping validation documentation up-to-date, and manage periodic reviews of relevant computerized systems;Maintain the EUBPT computerized systems "Inventory List";Collaborate with internal/supplier audit teams during audits in the GAMP area. Qualifications:HARD SKILLSPrevious experience in Computer Systems Validation, preferably in the pharmaceutical industry or life sciences, with at least 6 months to 1 year of experience;Knowledge of GMP Regulation for computer systems (EU GMP volume 4 annex 11; CFR 21 part 11) is preferable;Familiarity with CFR Part 11 and EU GMP Annex 11 principles is a plus;Knowledge of GAMP guidance;Fluent in Italian and English - both written and spoken. SOFT SKILLSAnalytical mindset and problem-solving orientation;Strong communication skills and a team-oriented attitude;Flexible and organized individual;Additional Information:To learn more about Eurofins, please explore our website.

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