Computer System Validation Specialist Milano

Computer System Validation Specialist
Milano
Lombardia, Milano

Job DescriptionEurofins BioPharma Product Testing (BPT) is looking for a Computer System Validation Specialist 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. ResponsibilitiesSupport validation activities;Collaborate on the evaluation of the changes to the computerized systems from a regulation and data integrity requirements perspective;Collaborate 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;Collaborate on the delivery of the Computerized Systems validation documents;Ensure that the system is maintained in the validated status along with its lifecycle, and its validation documentation is up-to-date.

Deal with the process of "periodic review" of the relevant computerized systems. Maintain the EUBPT computerized systems "Inventory List";Collaborate with internal/supplier audit team during audits in the GAMP area. QualificationsHARD SKILLSPrevious experience in the Computer Systems Validation role preferable in the pharmaceutical industry or life sciences, with at least 6 months/1 year of experience. Knowledge of GMP Regulation for computer systems (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 SKILLSAnalytical mindset and problem-solving oriented;Strong communication skills and team working attitude;Flexible and organized person; #J-18808-Ljbffr