- 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.
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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