QA Sterility Lead - 12 month

Job description

Job Responsibilities;

  • The QA Sterility Lead will help in developing clean utilities and environmental monitoring program for the site.
  • Developing training programme for aseptic processing with the operations team as well as providing relevant aseptic trianing to site.
  • The QA Sterility Lead is responsible for the site Contamination Control Strategy.
  • Establish, in conjunction with the operations function, the sites gowning strategy and cleaning and sanitization program
  • Review/ Monitor/review microbiological data in order to observe trends.
  • Liaise with the global science and technology team to ensure best practices are in place concerning sterility assurance
  • Provide technical guidance on any contamination related to non-conformances or events.
  • Ensure that the site is operating under governing regulations for sterility assurance
  • Participate in method transfer for relevant microbiological tests to site.

Job Requirements;

The QA Sterility Lead will have a relevant degree with 4 years relevant pharmaceutical experience in quality or operations.

They will also have at least 1 years aseptic sterile fill-finish experience.

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