- Support validation activities;
- Assist in evaluating changes to computerized systems from a regulatory and data integrity perspective;
- Investigate and address compliance issues such as Deviation and CAPA;
- Review User Requirements and Software Specifications to ensure systems are designed according to regulatory and data integrity requirements;
- Contribute to the delivery of Computerized Systems validation documents;
- Ensure systems maintain validated status throughout their lifecycle and keep validation documentation up-to-date;
- Maintain the EUBPT computerized systems Inventory List;
- Participate in internal/supplier audits in the GAMP area.
- Prior experience in Computer Systems Validation in pharmaceutical or life sciences field, 6 months to 1 year preferred;
- Knowledge of GMP Regulations for computer systems (EU GMP-volume 4 annex 11; CFR21 part 11) preferred;
- Familiarity with CFR Part 11 and EU GMP Annex 11 principles advantageous;
- Understanding of GAMP guidance;
- Proficient in technical English writing and speaking.
- Analytical and problem-solving abilities;
- Effective communication and teamwork;
- Organized and flexible approach;
- Location preference: Vimodrone or Milan.
- Opportunity for Smart Working;
- Flexible work hours;
- Meal Vouchers €8/day;
- Support for professional development.
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Junior Computer System Validation - Vimodrone, Italia - Eurofins Italy BioPharma Product Testing
