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Sterility Assurance Lead Jobs

Sterility Assurance Lead Jobs
By Baxter International Inc. At Mississauga, Ontario, Canada
Knowledge and application of computer systems for word processing, reporting, data analysis and NCR/CAPA, and Change Control Management
Manage the Environmental Monitoring program and ensure compliance with applicable regulatory and corporate requirements.
Lead cross-functional teams in performing Environmental Performance Qualifications, Process Failure Modes and Effect Analysis, and Real Time Risk Assessment per requirements
Investigate all Sterility Assurance related exceptions (e.g. Micro OOLs, Particulate Matter OOLs, Qualification failures); coordinate and document follow-up actions
Manage audit readiness for Sterility Assurance, and host/participate in internal and external inspections
Ensure local SOPs are up to date and aligned with requirements and applicable regulatory standards