Company Description Con 900 laboratori, circa 61.000 dipendenti, oltre 200.000 metodi analitici, una presenza diffusa in 54 paesi e un fatturato annuo di 6.7 BIL EUR, Eurofins Scientific è un gruppo internazionale leader nei servizi analitici conto terzi nei settori Farmaceutico, Alimentare, Ambientale e Consumer Products. Eurofins nell’ottica di potenziare la sua divisione BioPharma, al fine di fornire valore a clienti di tutto il mondo, è alla continua ricerca di persone fortemente motivate e orientate al raggiungimento dei risultati che vogliano entrare a far parte di una realtà solida e dinamica. Job Description Eurofins BioPharma Product Testing (BPT) is looking for a _Junior_ _Computer System Validation _based in Vimodrone (MI),_ _that will collaborate with the European CSV Coordinator to assure the GMP compliance requested for all the computerized systems in use in the Eurofins European Biopharma Product Testing. Main tasks: - Support validation activities; - Collaborates on the evaluation of the changes to the computerized systems from a regulation and data integrity requirements perspective; - Collaborates on the investigation and resolution of compliance issues that may arise (Deviation and CAPA). - Verify if a computerized system is designed according to the applicable regulatory and data integrity requirements: review of User Requirements and Software Specifications; - Collaborates on the delivering of the Computerized Systems validation documents; - Collaborates to ensure that the system is maintained in the validated status along with its lifecycle, and its validation documentation up-to-date. Deal with the process of “periodic review” of the relevant computerized systems. - Maintains updated the EUBPT computerized systems “Inventory List”; - Collaborates with internal/supplier audit team during audit in GAMP area. Qualifications: - HARD SKILLS_ - Previous experience in the Computer systems Validation role preferable in pharmaceutical industry or life sciences, with at least 6 months/1 year of experience. - Knowledge of GMP Regulation for computer system (EU GMP-volume 4 annex 11; CFR21 part 11) is preferable; - Knowledge of CFR Part 11 and EU GMP Annex 11 principles is considered a plus; - Knowledge of GAMP guidance; - Fluent knowledge of Italian and English - both written and spoken - SOFT SKILLS_ - Analytical mindset and problem-solving oriented; - Strong communication skills and team working attitude; - Flexible ad orginazed person; - Vimodrone or Milan based. Additional Information - Orario Flessibile; - Ticket Restaurant 8€/giorno; - Welfare aziendale; - Molteplici corsi di formazione e supporto allo sviluppo del personale. Non saranno presi in considerazione CV privi di questi requisiti. L'inserimento iniziale sarà a contratto determinato o apprendistato, con finalità assuntive. Ingresso previsto per il 16 luglio.