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As a V.I.E. in the Life Sciences division, you will support the validation and compliance of computerized systems used in regulated environments, ensuring that GxP systems meet regulatory standards. You’ll contribute to audits, stay informed on evolving regulations (EMA, FDA, GAMP, ISO), and work closely with Sopra Steria’s validation service teams. This position offers the opportunity to gain international experience and collaborate with industry experts.
Job Responsibility:
Support the validation and compliance of computerized systems used in regulated environments
ensure GxP systems meet regulatory standards throughout their lifecycle
contribute to audits
stay informed on evolving regulations (EMA, FDA, GAMP, ISO)
work closely with Sopra Steria’s validation service teams.
Requirements:
Strong interest in CSV
strong affinity with IT
analytical and pragmatic thinking skills
strong prioritization and planning skills
strong sense of responsibility and accountability
a positive, solution-driven mindset
excellent written and oral communication skills in English
basic knowledge of IT infrastructure qualification
a team player, but also able to work independently
familiar with applicable regulatory standards and guidelines (21CFR Part 11, EU Annex 11, GDPR, GAMP5, ISO 9001,...) and concepts such as QMS, CAPAs, Data Integrity,...
familiar with applying validation methodologies (Waterfall, Agile) within a GxP environment.
What we offer:
An international experience: be part of an innovative company with global reach
a stimulating environment: work on ambitious projects and collaborate with industry experts
a dynamic company culture: join a human-sized team within a large group
career growth opportunities: potential for long-term career development in Canada or within the Sopra Steria Group.
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