Sterility Assurance Lead at Apotex

Drive sterility assurance excellence at Apotex as a Sterility Assurance Lead in Richmond Hill. Oversee contamination control, regulatory readiness, and compliance in aseptic processing operations.

As part of Apotex, a leading global health company, the Sterility Assurance Lead is responsible for maintaining effective sterility assurance strategies and managing daily operations to meet regulatory standards. This role requires a strong background in contamination control, aseptic manufacturing, and risk management, while collaborating with Quality, Engineering, and cross-functional teams to embed sterility principles into everyday practices.

Key Responsibilities: • Maintain contamination control and continuous inspection readiness • Own and enhance the Contamination Control Strategy lifecycle • Act as technical authority on sterility assurance decisions • Ensure compliance with FDA, ICH, and EU GMP Annex 1 regulations • Provide governance for programs and lead regulator...