Junior Computer System Validation

Overview Company Description Con oltre 900 laboratori, circa 63.000 dipendenti, oltre 200.000 metodi analitici, una presenza diffusa in 62 paesi e un fatturato annuo di 6.7 BIL EUR, Eurofins 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. Eurofins BioPharma Product Testing è alla ricerca di una risorsa da inserire nel team per supportare la conformità GMP dei sistemi computerizzati in uso. Role Junior Computer System Validation based in Vimodrone (MI) , che collaborerà con il European CSV Coordinator per assicurare la conformità GMP richiesta per tutti i sistemi computerizzati utilizzati nell’Eurofins European Biopharma Product Testing. La risorsa riporterà al EBPT CSV Coordinator e al Quality / Compliance Director . Responsibilities Execute Computerized Systems validation and Infrastructure qualification activities. Collaborate on the evaluation of changes to computerized systems / infrastructure components from regulatory and data integrity perspectives. Collaborate on investigation and resolution of compliance issues (Deviation and CAPA). Verify that a computerized system (including infrastructure) is designed according to applicable regulatory and data integrity requirements: review of User Requirements and Software / Infrastructure Specifications. Collaborate on delivering Computerized Systems validation and Infrastructure Qualification documents. Ensure that the system / infrastructure is maintained in validated / qualified status along with its lifecycle and that validation / qualification documentation is up to date. Handle the periodic review process for relevant computerized systems / infrastructure components. Keep the EUBPT computerized systems Inventory List updated. Collaborate with internal / supplier audit teams during audits in the GAMP area. Qualifications Professional Experience: Experience in Quality area with knowledge of computer systems related quality processes (e.g., Change Control, Deviation, CAPA); Computer System Compliance and Validation Life Cycle; CFR Part 11 and EU GMP Annex 11 principles. Experiences in IT areas with knowledge of computerized systems typically used in Pharma Laboratory environments or equivalent. Professional knowledge Computerized systems used in analytical laboratories (e.g., CDS, LIS, LIMS). Infrastructure components (e.g., Router, Access Point, Firewall). GAMP guidance; GMP Regulation for computer systems (EU GMP Volume 4 Annex 11; CFR 21 Part 11) and pharma industry (EU GMP Volume 4, CFR 21 Part 210, 211). Data governance and data integrity principles. Managerial Skills Problem solving; Team working / collaboration; Precision and control; Flexibility: planning and organizing. Benefits Orario Flessibile Ticket Restaurant 8€ / giorno Company Welfare How to apply To apply it is necessary to send a detailed CV and cover letter, specifying the authorization to process personal data. CVs without these requirements will not be taken into consideration. The hiring will be with a fixed contract (with permanent hiring purpose). To learn more about Eurofins, please explore our website J-18808-Ljbffr

Location: Plasencia, Emilia-Romaña, IT

Posted Date: 9/7/2025