Company Description
Sopra Steria offers tailored, end-to-end corporate technology and software solutions to help clients make bold choices and deliver results. Successfully so! With more than 51.000 colleagues in 30 countries, we rank as Europe’s leading digital solutions provider. Some of the most successful companies in Europe rely on our technology due to our commitment to innovation, collaboration, and value in business development.
The world is how we shape it. Let’s shape it together.
Job Description
As a quality and compliance expert, you will be responsible for ensuring that GxP systems and processes adhere to the applicable regulatory requirements throughout the entire system lifecycle. Therefore, you stay up to date about evolving regulations from authorities such as the EMA and FDA and industry standards like GAMP and ISO. Depending on your role and expertise, you may be asked to provide Quality & Compliance support during audits and inspections, or to join a Sopra Steria validation service team.
As a trusted Computerized System Validation (CSV) Engineer, you play a key role in the validation process of the computerized systems used by our clients in the Life Sciences sector. More specifically, your mission is to ensure the quality and regulatory compliance of GxP systems throughout their entire life cycle and across all GxP areas (GLP, GCP, GMP, GDP, GPvP). Systems in scope can include site-specific lab instruments (e.g. HPLC software) and production equipment (e.g. capsule filling machine), but also globally used web applications, Clinical Trial Management Systems, complex Manufacturing Execution Systems, SAP systems, medical devices, etc…
Qualifications
We’re seeking passionate colleagues who are eager to push the boundaries in digital transformation and technology consulting. At Sopra Steria, you’ll have the opportunity to grow your skills in a constructive, collaborative team environment, working on impactful projects that drive change for our clients. If you thrive on challenge and meet (most of) the qualifications below, we look forward to your application!
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Proven CSV experience in multiple projects or strong interest in CSV
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Strong affinity with IT
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Analytical and pragmatic thinking skills
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Strong prioritization and planning skills
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Strong sense of responsibility and accountability
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A positive, solution-driven mindset
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Excellent written and oral communication skills in Dutch and English
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Basic knowledge of IT infrastructure qualification
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A team player, but also able to work independently
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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,... .
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Familiar with applying validation methodologies (Waterfall, Agile) within a GxP environment.
Additional Information
Are you ready to further develop your career? Then we'd love to point you in the right direction. With offices in more than 30 countries, that direction might lead you to places you've never been to before. Would you prefer to grow internally? That's possible, too. We challenge you to keep pushing yourself to become the best you can be.
We offer a generous employee benefits package that includes:
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A variety of perks, such as mobility options (including a company car), insurance coverage, meal vouchers, eco-cheques, and more.
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Continuous learning opportunities through the Sopra Steria Academy to support your career development.
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The opportunity to connect with fellow Sopra Steria colleagues at various team events.
Ready to take the next step? We’re here to support you all the way and we are looking forward to you application!
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Sopra Steria is an equal opportunity employer. All qualified applicants will be considered for employment without regard to age, ancestry, nationality, color, family or medical leave, gender identity or expression, genetic information, immigration status, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran or military status, race, ethnicity, religion, gender (including pregnancy), sexual orientation or any other characteristic protected by applicable local laws, regulations and ordinances. We foster a work environment that is inclusive and respectful of all differences.
