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Computer Systems Validation Expert

2 mesi fa

Milano, Lombardia, Italia Eurofins Horti A tempo pieno

Job Description

Eurofins BioPharma Product Testing is seeking a highly skilled Computer Systems Validation Expert to collaborate with the European CSV Coordinator in ensuring GMP compliance for all computerized systems in use within the Eurofins European Biopharma Product Testing.

Responsibilities:

  • Support validation activities
  • Collaborate on the evaluation of changes to computerized systems from a regulation 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
  • Ensure that the system is maintained in the validated status along with its lifecycle, and its validation documentation is up-to-date
  • Deal with the process of periodic review of relevant computerized systems
  • Maintain the EUBPT computerized systems Inventory List
  • Collaborate with internal/supplier audit team during audits in the GAMP area

Qualifications:

  • Previous experience in the Computer Systems Validation role, preferable 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

Key Skills:

  • Strong analytical mindset and problem-solving oriented
  • Strong communication skills and team working attitude
  • Flexible and organized person