Sterility Assurance Lead

Job description

Job Responsibilities:

  • Work closely with the operations group to develop a training program for aseptic processing
  • The Sterility Assurance Lead will provide training in aseptic behaviours and principles to the site
  • Partner with the QC Micro Lab to develop the clean utilities and environmental monitoring program for the site
  • Establish, in conjunction with the operations function, the sites gowning strategy and cleaning and sanitization program
  • Monitor and review microbiological data to detect trends
  • You will liaise with the global science and technology team to ensure best practices are in place concerning sterility assurance
  • The Sterility Assurance Lead will provide technical guidance on any contamination related to non-conformances or events.
  • Ensure that the site is operating under governing regulations for sterility assurance
  • Collaborate with cross-functional teams for the transfer of microbiological test methods to the site
  • Maintain and develop site practices for contamination control etc. utilizing training and a purposeful presence on the operations floor

Job Requirements

  • Third level qualification to degree level in a relevant technical discipline, ideally microbiology, science/engineering.
  • Minimum 4 years’ experience in the pharmaceutical industry or biopharma industry in a Quality/Operations role
  • Minimum 1 years’ experience in an aseptic sterile fill-finish manufacturing environment


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