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.
Overview
Eurofins BioPharma Product Testing (BPT) is looking for a Junior Computer System Validation based in Vimodrone (MI). The role collaborates with the European CSV Coordinator to assure GMP compliance for all computerized systems used in the Eurofins European Biopharma Product Testing. The position reports to the EBPT CSV Coordinator and 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. Assist in the 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. Contribute to delivering the Computerized Systems validation and Infrastructure Qualification documents. Ensure that the system / infrastructure remains in a validated / qualified state throughout its lifecycle and that validation / qualification documentation remains up to date. Support periodic reviews of relevant computerized systems / infrastructure components. Maintain the EUBPT computerized systems Inventory List. Collaborate with internal / supplier audit teams during audits in the GAMP area.
Qualifications
Professional Experience: Experience in Quality areas 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; IT experience with computerized systems typically used in Pharma Laboratory environments or equivalent working areas.
Professional Knowledge: Computerized systems 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; CFR21 Part 11) and pharma industry knowledge (EU GMP Volume 4, CFR21 Part 210, 211); Data governance and data integrity principles.
Managerial Skills : Problem solving; Teamwork; Precision and control; Flexibility : planning and organizing.
Additional Information
* Orario Flessibile; Ticket Restaurant 8€ / giorno; Company Welfare
To apply it is necessary to send a detailed CV and cover letter, specifying authorization to process personal data. CVs without these requirements will not be considered. The hiring will be with a fixed contract (with permanent hiring purpose).
To learn more about Eurofins, please explore our website
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