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
Job Description Eurofins BioPharma Product Testing (BPT) is looking for a Junior Computer System Validation professional based in Vimodrone (MI) who 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.
Responsibilities
* Execute Computerized Systems validation and Infrastructure qualification activities.
* Collaborate on the evaluation of changes to computerized systems / infrastructure components from a regulation and data integrity perspective.
* Collaborate on 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.
* Collaborate on delivering Computerized Systems validation and Infrastructure Qualification documents.
* Ensure that the system / infrastructure is maintained in the validated / qualified status throughout its lifecycle, with up-to-date validation/qualification documentation.
* Manage the periodic review process for 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: Experiences 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 working areas.
* 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; CFR21 part 11) and pharma industry (EU GMP volume 4, CFR21 part 210, 211); Data governance and data integrity principles.
Managerial Skills
* Problem solving
* Team working / collaboration
* Precision and control
* Flexibility: planning and organizing
Benefits / Additional Information
* Orario Flessibile
* Ticket Restaurant 8€ / giorno
* Company Welfare
To apply it's 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
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