Computer Systems Validation Expert

4 settimane fa


Milano, Lombardia, Italia Eurofins Usa A tempo pieno

Job Description
Eurofins BioPharma Product Testing is seeking a highly skilled Computer Systems Validation Specialist to collaborate with the European CSV Coordinator to ensure GMP compliance for all computerized systems in use across the Eurofins European Biopharma Product Testing network.

Responsibilities
• Support validation activities
• Collaborate on the evaluation of changes to computerized systems from a regulatory and data integrity requirements perspective
• Collaborate on the investigation and resolution of compliance issues that may arise (Deviation and CAPA)
• Verify if a computerized system is designed according to applicable regulatory and data integrity requirements: review of User Requirements and Software Specifications
• Collaborate on the delivery of Computerized Systems validation documents
• Collaborate to ensure that the system is maintained in a validated status along with its lifecycle, and its validation documentation is up-to-date

Qualifications
• Previous experience in the Computer Systems Validation role, preferably in the pharmaceutical industry or life sciences, with at least 6 months/1 year of experience
• Knowledge of GMP Regulation for computer systems (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

Additional Information
To learn more about Eurofins, please explore our website: www.eurofins.com, www.eurofins.it



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