Capgemini is a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided everyday by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of 270,000 team members in nearly 50 countries. With its strong 50 year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2020 global revenues of €16 billion.
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At Capgemini Engineering we value excellence, care, responsibility, dynamism and innovation. We offer a job with variation that leaves plenty of room for initiative and development. In fact, we are not just offering you a job, we’re inviting you to be part of our community where we will provide you trainings, tools & grounds for professional and personal growth. Each career experience is assorted by an attractive salary package.
If you are a team player, if you recognize yourself in this profile and are not afraid of taking on challenges… Apply today!
- You will help define and support the Validation Approach,
- You will establish procedures for Validation in accordance with international standards (FDA, EMA, ICH, ASTM E2500, GAMP),
- You will write Validation documents (protocols, reports, SOPs, Critical Impact Assessments, …)
- You will manage deviations,
- You will coordinate and execute validation (IQ, OQ, PQ) tests,
- You will perform risk assessments,
- You will work in close collaboration with production, engineering, maintenance, QC, QA…
- You will ensure handover with final users,
- You will ensure QA oversight in validation activities (IQ/OQ/PQ…),
- You will ensure timely escalation to management of critical issues during validation,
- You will define the validation strategies in accordance with the regulatory requirements,
- You will attend all project meetings as (QA) validation representative.
- Master degree in engineering or related scientific domains,
- Native level of French or Dutch and fluent in English,
- At least 2 years of relevant experience in Validation in a GMP environment is mandatory,
- Knowledge of management (project/team management),
- Good interpersonal relationship skills,
- Problem solving and achievement oriented,
- Be a good team player in order to succeed in each validation project,
- Be able to use a risk-based approach for problem solving and prioritization of tasks.