Computerized System Validation Specialist
Há 1 mês
About Us
We are Capgemini Engineering, a brand part of the Capgemini Group.
Our mission is to empower every person and every organization on the planet to achieve more.
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 to the day-to-day business activity, namely in the CSV/QA area.
This position is open for various locations.
Key Responsibilities
- 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.
About You
We're looking for someone with:
- Academic degree in biomedical engineering, pharmaceutical sciences, IT or computer science or related fields;
- Previous experience in computerized system validation – CSV, ideally 2 to 5 years;
- Strong knowledge of GxP regulations and guidelines;
- Solid verbal and written communication skills in English (at least B2).
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