Connecting...

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.

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.