Description
OPTEL is hiring a Validation Specialist to create and maintain validation documentation, including internal protocols, IQ, OQ, and change controls, for traceability systems. The role manages validation templates, supports regulatory compliance with GAMP, FDA 21 CFR Part 11, and EU Annex 11, generates client documentation, executes validation protocols, performs risk analysis, leads root-cause investigations, and collaborates with internal teams and clients. Candidates need a relevant college diploma, at least two years of experience in system testing and validation or technical writing, English proficiency, advanced Microsoft Office skills, and familiarity with VBA; knowledge of AI tools is an asset. Benefits include competitive compensation, flexible working hours, an employee assistance program, and a comprehensive group insurance plan.
