Lifesciences Consultant

3 semanas atrás

Lisboa, Portugal Capgemini Engineering Tempo inteiro

**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.

**You can help us to achieve our mission **

Now, we have more than 270,000 team members in nearly 50 countries, in sectors such as aeronautics, automotive, communications, energy, life sciences, software & internet, space & defense and consumer products.

**Profile**:
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).

**Nice-to-have**:
+2 years in Medical devices industry;
Knowledge in ISO 13485, ISO 19471 and/or EN 62304;
Verbal and written communication skills in French.

**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.

**This position is open for Lisbon, Porto & Fundão.**

**Your role**:
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.

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