QA Validation Consultant Life Sciences
il y a 1 jour
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.
- 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.
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