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As our QA Sterility Assurance Manager you will be the primary contact for sterility assurance, aseptic and bioburden controlled processes and environmental monitoring.
Key Responsibilities:
Lead the Sterility Assurance team of 9, manage their work performance, define workload priorities, organize and control their activities
Escalate appropriately to site leadership team and Global Quality Assurance issues/risks associated with Sterility and Environmental Monitoring
Maintain and ensure aseptic procedures are in place and in use
Support investigations where aseptic assurance is at risk
Oversight of microbial control strategy
Establish and monitor Sterility Assurance and EM Key Performance Indicators
Perform internal audits against cGMP rules, company policies and procedures, and the authority regulations concerning Sterility Assurance topics.
Review and appr...