Job Description
Job Summary
This is a Quality position for the Richmond Hill site to ensure all GMP facilities, utility systems, equipment, and processes for both sterile and non‑sterile manufacturing are fully validated and in compliance with current corporate and regulatory requirements.
Job Responsibilities
- Provide Quality direction and approval to ensure all validation activities/status are conducted and maintained in accordance with corporate policies and regulatory requirements.
- Accountable for the maintenance of and continuous improvement to all sterile and cleaning validation, including but not limited to:
- Aseptic Process Simulations (media fills)
- Aseptic operator qualification
- Thermal (moist / dry heat) and gaseous (VHP / ETO) validation
- Irradiation (gamma / e‑beam) of primary packaging components
- Container closure integrity
- Sterilizing filter validation
- Equipment cleaning v...