Found 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 validation & routine monitoring...
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 validation & routine monitoring...
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