Description du poste
As 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.
Qualifications
Master’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.