Coordinator, Sterile Validation (Contract Role)

The Coordinator, Sterile Validation ensures all sterile validation activities at the Apotex Richmond Hill site comply with corporate policies and regulatory guidelines like FDA and ICH. Incumbents work cross-functionally with Engineering, Production, and Quality to execute sterilization process validations, air flow studies, and aseptic process simulations. The role involves generating protocols, completing summary reports, assessing production changes, and preparing validation documentation for regulatory submissions.