CSV Consultant

at  CAPGEMINI ENGINEERING

COMPANY

We are Capgemini Engineering. A brand part of the Capgemini Group.
We have the mission to empower every person and every organization on the planet to achieve more. Our culture is centered on embracing a growth mindset, diversity, inclusion, a purpose of inspiring excellence, and encouraging teams and leaders to bring their best each day. In doing so, we create life-changing innovations that impact billions of lives around the world.

ABOUT THE JOB

We’re seeking a partner who shares knowledge, responsibility and commitment in the execution of activities related with the day-to-day business activity, namely in the CSV/QA area.

Perform as a CSV engineer supporting computerized system validation and IT qualification of applications and software;
Anticipate and advise about GxP-regulated and regulatory compliance computerized validation processes needs based on each system specifications;
Perform QA activities supporting Medical Devices software development projects;
Perform end-to end validation to verify software (validation planning, test protocols and reports, risk assessments);
Work within a team with specific roles following regulations and guidelines interacting with other teams and stakeholders;
Share knowledge about computerized system validation and medical devices.