Consultant System Validation Life Science
BE-BE-BRU-Brussels
English Portal
Req #: 39083
Type: Permanent
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Overview: Expleo offers a unique offering of integrated engineering, quality and strategic consulting services for digital transformation. In a context of unprecedented technological acceleration, we are the trusted partner of innovating companies. We help them develop a competitive advantage and improve the daily lives of millions of people. Present in 30 countries and with 19,000 employees, we support our customers on a daily basis. As part of our teams, you will carry out various advisory and support missions with our clients. Joining Expleo means: * Technical support in the field Continuing training via our technical experts * Human values among our employees * The diversity of our teams An increase in skills throughout your career * Work on large-scale projects Responsibilities: What is your role? As part of the design, modification or validation of production equipment dedicated to the pharmaceutical sector, we are looking for new employees to join Expleo Life Sciences Belgium. If you want to invest in validation projects for computerized systems and/or automated systems in accordance with the appropriate regulations, then this role is made for you. What is your responsibility? * Participation in the development and implementation of models for the validation of the various systems; * Involvement in the definition of user and functional needs for new systems as well as existing ones subject to validation; * Review and validation of the documentation related to the different validation phases (IQ, OQ, PQ, URS and traceability matrix); * Execution and monitoring of system tests; * Creation of validation protocols and reports; * Guarantee of project monitoring and regulatory constraints; * Realization of Data Integrity audit. Qualifications: * You have an engineering degree or an equivalent; * You have at least 3 years of experience in the pharmaceutical or biopharmaceutical sector; * You are familiar with the different regulations: GMP; GAMP 5, 21 CFR 1; * You speak French and/or Dutch and have a good level of English. #LI-EM1
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