Responsibilities

You collaborate within the group to implement best practices related to data integrity/CSV and ensure regulatory watch on these issues.
You define the validation strategy for computerized and automated systems.
You review and approve design documentation to ensure alignment with system requirements and GxP guidelines.
You guide on-site teams with regard to data integrity requirements.
You write and review validation plans, protocols and reports.
You monitor the execution of qualification and validation activities.
You establish test protocols in collaboration with the IS department.
You are the expert who answers questions relating to data integrity/validation of computerized systems during regulatory inspections and customer audits.
You ensure that the validated state of computerized systems is maintained through periodic review activities, in compliance with cGMP throughout the system’s lifecycle.
You ensure the compatibility and control of data management for each system, guaranteeing their long-term availability according to critical data archiving requirements.
You review/approve deviations/changes and CAPAs related to computerized systems and/or data integrity.

Profile

You have a Master’s degree in biomedical engineering or computer science.
You have at least 3 years’ experience in a similar role.
You have proven expertise in Data Integrity.
You have a good command of GMP, GMP, GAMP 5 and ALCOA+ standards.
Good command of English.
You have a good knowledge of MS Office suite.
Excellent organizational skills.
You have the ability to think on your feet and have a strategic vision.
You have initiative and the ability to make decisions.
You are synthetic, analytical and solution-oriented.

Do you want to become a major player in the global fight against cancer?

At Trasis, we give you the opportunity to work with cutting-edge technologies and contribute to the improvement of cancer diagnosis and therapy techniques. Through your actions, you will have the opportunity to have a positive impact on the services provided to users and patients.

The opportunity to participate in building and improving processes in a growing company.

We offer a young and friendly work atmosphere, a flexible and dynamic environment.

An attractive and flexible salary according to your experience and performance, with extra-legal benefits.

CSV Engineer

CSV Engineer