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 fields
· You fulfill the eligibility criteria for the V.I.E program
· You are able to work in English as well as French
· Curious 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.