Company Description
Con 900 laboratori, circa 61.000 dipendenti, oltre 200.000 metodi analitici, una presenza diffusa in 54 paesi e un fatturato annuo di 6.7 BIL EUR, Eurofins Scientific è un gruppo internazionale leader nei servizi analitici conto terzi nei settori Farmaceutico, Alimentare, Ambientale e Consumer Products.
Eurofins nell’ottica di potenziare la sua divisione BioPharma, al fine di fornire valore a clienti di tutto il mondo, è alla continua ricerca di persone fortemente motivate e orientate al raggiungimento dei risultati che vogliano entrare a far parte di una realtà solida e dinamica.
**Job Description**:
**Eurofins BioPharma Product Testing** (BPT) is looking for its site in Vimodrone (MI) a **_Computer System Validation Specialist_** 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. The role will report to the Quality and Compliance Director.
**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.
**Qualifications**:
- Professional Experience_
- Experiences in Quality area with knowledge on:
- Computer systems related quality processes (e.g. Change Control, Deviation, CAPA);
- Computer System Compliance and Validation Life Cycle;
- CFR Part 11 and EU GMP Annex 11 principles;
- experiences in IT areas with knowledge on computerized systems typically used in Pharma Laboratory environments or equivalent working areas.
- Professional Knowledge_
- Computerized system to analytical laboratory (e.g. CDS, LIS, LIMS);
- GAMP guidance;
- GMP Regulation for computer system (EU GMP-volume 4 annex 11; CFR21 part 11) and pharma industry (EU GMP volume 4, CFR21 part 210, 211);
- Data governance and data Integrity principle;
- Managerial Skills _
- Problem solving;
- Team working/working together;
- Precision and control;
- Flexibility: planning and organizing.
Additional Information
- Possibility of Lavoro da remoto;
- Flexible schedule;
- Ticket Restaurant €8/day;
- Professional development support.
To apply, it is necessary send a detailed Curriculum Vitae, specifying the authorization to process personal data. CVs without these requirements will not be considered.
📌 Computer System Validation Specialist
🏢 Eurofins Italy Biopharma Product Testing
📍 Vimodrone