Con oltre 900 laboratori, circa 63.7 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 (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.
The role will report to the EBPT CSV Coordinator and Quality/Compliance Director.
Collaborates on the evaluation of the changes to the computerized systems/infrastructure components 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 (infrastructure included) is designed according to the applicable regulatory and data integrity requirements: review of User Requirements and Software/Infrastructure Specifications;
Collaborates to ensure that the system/infrastructure is maintained in the validated/qualified status along with its lifecycle, and its validation/qualification documentation up-to-date. Maintains updated the EUBPT computerized systems “Inventory List”;
Collaborates with internal/supplier audit team during audit in GAMP area.
Experiences in Quality area with knowledge on:
Computer systems related quality processes (e.g. Change Control, Deviation, CAPA);
Computer System Compliance and Validation Life Cycle;
CDS, LIS, LIMS);
GMP Regulation for computer system (EU GMP-volume 4 annex 11; Data governance and data Integrity principle.
Precision and control;
Flexibility: planning and organizing.
Orario Flessibile;
To apply it's necessary to send a detailed CV and cover letter, specifying the authorization to process personal data. The hiring will be with a fixed contract (with permanent hiring purpose).