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Responsibilities
About the roleAs a Validation and Qualification Consultant, your skills will support the projects of our partners involved in the production of pharmaceuticals or health-related products. You will play a central role in coordinating and executing the validation cycle to successfully complete projects within specified timelines.To achieve this, you will:Represent the Validation department in various projects.Design and implement the best validation strategy.Coordinate project planning with all stakeholders (production / QA / maintenance).Participate in risk assessment through the preparation of a « Risk assessment. »Contribute to the definition and drafting of Functional Specifications (FS) and Design Specifications (DS).Write protocols, coordinate and ensure the smooth conduct of tests (URS / FAT / SAT / IQ / OQ / PQ).Analyze and interpret results to write resulting reports.Develop training programs and coach operators in the field.Manage deviations related to validation runs and implement associated CAPAs.QualificationsMaster’s degree in Bio-Engineering, Industrial Pharmacy or related fieldsYou fulfill the eligibility criteria for the V.I.E programYou are able to work in English as well as FrenchCurious to learn more about production equipment and/or manufacturing processes.Organized and meticulous in the preparation of your GMP documents.Communicative and enjoy interactions with different departments such as Production, Quality Assurance, and Maintenance.
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