Junior Computer System Validation

Eurofins

  • Milano
  • Tempo indeterminato
  • Full time
  • 10 giorni fa
Company DescriptionCon 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.Job DescriptionEurofins 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.Responsibilities:
  • Execute Computerized Systems validation and Infrastructure qualification activities;
  • 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 on the delivering of the Computerized Systems validation and Infrastructure Qualification documents;
  • 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. Deal with the process of “periodic review” of the relevant computerized systems/infrastructure components.
  • Maintains updated the EUBPT computerized systems “Inventory List”;
  • Collaborates with internal/supplier audit team during audit in GAMP area.
QualificationsProfessional Experience
  • 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;
  • CFR Part 11 and EU GMP Annex 11 principles;
  • Experiences in IT areas with knowledge on computerized systems typically used in Pharma Laboratory environments or equivalent working areas.
Professional knowledge
  • Computerized system to analytical laboratory (e.g. CDS, LIS, LIMS);
  • Infrastructure components (e.g. Router, Access Point, Firewall);
  • GAMP guidance;
  • GMP Regulation for computer system (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 principle.
Managerial Skills
  • Problem solving;
  • Team working/working together;
  • Precision and control;
  • Flexibility: planning and organizing.
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 www.eurofins.com, www.eurofins.it

Eurofins