Job Description

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...

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