- 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
- 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
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.