Eurofins BioPharma Product Testing (BPT) is looking for a Computer System Validation Specialist 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.
Main tasks:
- 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.
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.
- Orario Flessibile;
- Ticket Restaurant 8€/giorno;
- Welfare aziendale;
- Molteplici corsi di formazione e supporto allo sviluppo del personale.
Per candidarsi è necessario inviare CV dettagliato e lettera di presentazione, specificando l'autorizzazione al trattamento dei dati personali.
Non saranno presi in considerazione CV privi di questi requisiti. L'inserimento iniziale sarà a contratto determinato o apprendistato, con finalità assuntive. Ingresso previsto per il 15 Ottobre.
To learn more about Eurofins, please explore our website www.eurofins.com, www.eurofins.it
