Data Validation Specialist
Há 3 dias
About Us - Capgemini Engineering is a leading brand within the Capgemini Group. Our mission is to empower individuals and organizations worldwide to achieve more. We foster a culture centered around embracing growth, diversity, inclusion, and inspiring excellence.
The Job - We're seeking a skilled partner to collaborate on activities related to day-to-day business operations in the CSV/QA area. This role is open for Lisbon, Porto & Fundão locations.
Your Role - As a CSV engineer, you will support computerized system validation and IT qualification of applications and software. Your responsibilities include anticipating and advising on GxP-regulated and regulatory compliance computerized validation processes based on system specifications. Additionally, you will perform QA activities supporting Medical Devices software development projects, conduct end-to-end validation to verify software (validation planning, test protocols and reports, risk assessments), and work collaboratively within a team following regulations and guidelines while interacting with other teams and stakeholders. You will also share knowledge about computerized system validation and medical devices.
Your Profile - To succeed in this role, you should have an 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, is required. You should possess strong knowledge of GxP regulations and guidelines, as well as solid verbal and written communication skills in English (at least B2).
Salary Range - Based on industry standards and location, we offer a competitive salary range of €50,000-€70,000 per annum, commensurate with experience. This figure may vary depending on individual qualifications and performance.
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