- Support validation activities;
- Participate in evaluating changes to computerized systems from a regulatory and data integrity perspective;
- Assist in investigating and resolving compliance issues (Deviations and CAPA);
- Review if computerized systems meet applicable regulatory and data integrity requirements by examining User Requirements and Software Specifications;
- Contribute to delivering Computerized Systems validation documents;
- Ensure systems remain validated throughout their lifecycle and keep validation documentation up-to-date. Handle the 'periodic review' process for relevant computerized systems;
- Maintain the inventory list of EUBPT computerized systems;
- Collaborate with internal/supplier audit teams during GAMP area audits.
- Prior experience in Computer Systems Validation role, preferably in the pharmaceutical industry or life sciences, with a minimum of 6 months to 1 year of experience;
- Familiarity with GMP Regulations for computer systems (EU GMP-volume 4 annex 11; CFR21 part 11) is preferred;
- Understanding of CFR Part 11 and EU GMP Annex 11 principles is advantageous;
- Knowledge of GAMP guidance;
- Proficiency in written and spoken English, including technical documentation.
- Analytical mindset and problem-solving skills;
- Effective communication abilities and a collaborative approach to teamwork;
- Flexible and organized individual;
- Location in Vimodrone or Milan preferred.
- Smart Working option available;
- Flexible work schedule;
- €8/day for Ticket Restaurant;
- Support for professional development.
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Junior Computer System Validation - Vimodrone, Italia - Eurofins
Descrizione
Job Description
Eurofins BioPharma Product Testing (BPT) is seeking a Junior Computer System Validation professional based in Vimodrone (MI), to collaborate with the European CSV Coordinator in ensuring GMP compliance for all computerized systems used in the Eurofins European Biopharma Product Testing.
Main Responsibilities:
Qualifications
HARD SKILLS
SOFT SKILLS
Additional Information
