Junior Computer System Validation

at  Eurofins Italy BioPharma Product Testing

Company Description
Con 900 laboratori, circa 61.000 dipendenti, oltre 200.000 metodi analitici, una presenza diffusa in 54 paesi e un fatturato annuo di 6.7 BIL EUR, Eurofins Scientific 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 Description
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.

HARD SKILLS

• Previous experience in the Computer systems Validation role preferable in pharmaceutical industry or life sciences, with at least 6 months/1 year of experience.
• Knowledge of GMP Regulation for computer system (EU GMP-volume 4 annex 11; CFR21 part 11) is preferable;
• Knowledge of CFR Part 11 and EU GMP Annex 11 principles is considered a plus;
• Knowledge of GAMP guidance;
• Fluent knowledge of Italian and English - both written and spoken

SOFT SKILLS

• Analytical mindset and problem-solving oriented;
• Strong communication skills and team working attitude;
• Flexible ad orginazed person;
• Vimodrone or Milan based.

• Support validation activities;
• Collaborates on the evaluation of the changes to the computerized systems 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 is designed according to the applicable regulatory and data integrity requirements: review of User Requirements and Software Specifications;
• Collaborates on the delivering of the Computerized Systems validation documents;
• Collaborates to ensure that the system is maintained in the validated status along with its lifecycle, and its validation documentation up-to-date. Deal with the process of “periodic review” of the relevant computerized systems.
• Maintains updated the EUBPT computerized systems “Inventory List”;
• Collaborates with internal/supplier audit team during audit in GAMP area.
  Qualifications