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description de la société
For a client in the pharmaceutical sector, we are looking for a Product Development Validation Coordinator to support validation activities for product development projects.
description de la fonction
You have an experience as quality validation technician ? This position is for you ! Contact me : Stessy_de_schutter@professionals.randstad.be
He / She will be integrated in the project team composed of engineering, quality, manufacturing, R&D, and support department.
He/She will be the representative of the product development team for validation activities and will provide the validation inputs at each phase of the product development project : - Project design phase : He / She will act as the reference for quality assurance guidance during the development phase o Consolidate the validation and quality requirements o Define and coordinate the project documentation preparation and review (URS / FS / DS) o Develop risk assessment (process FMEA, etc…) to allow to define the validation strategy and future in-process controls - Implementation phase : He/She will lead the validation activities during the implementation phase o Plan and coordinate of validation activities in alignment with the project timelines, follow up and reporting o Define the validation strategy in collaboration with the Quality Assurance Department o Ensure the traceability of activities throughout the whole project validation file (from URS to PQ). o Prepare protocols for FAT, IQ, OQ, PQ, process validation, cleaning validation and stability batches productions as required by the product development projects need and as defined within the validation strategy o Lead and coordinate the issue resolution in collaboration with the manufacturing, engineering and quality team o Analyze, interpret, document and report the testing results. o Prepare the reports for FAT, IQ, OQ, PQ, process validation, cleaning validation and stability batches productions as required by the product development projects need and as defined within the validation strategy
-Engineer, bachelor with 5 years’ minimum experience in validation, QA -Good Communication skills -Good problem solving and critical thinking skills -Good knowledge of English -Versatility, autonomy, rigor and reactivity -Good knowledge of current European and FDA regulations -Good knowledge in statistical analysis
Competitive salary package including all current extra-legal advantages.