Sterility Assurance Consultant

 

Lab Support is currently recruiting for a freelance Sterility Assurance Consultant based in Switzerland for a multinational medical device company.
 
Successful applicants will be reporting to the Sterility Assurance Manager and will be an experienced QA/validation specialist with experience of working within GMP regulated environments and conditions. You will be knowledgeable of gamma irradiation, ethylene oxide and moist heat sterilisation processes; and will be able to analyse gaps in the current sterilisation process and protocols, being able to implement changes where necessary.
 
The contract is due to run until the end of the year and rates are negotiable.

Required Skills:

 

 
Successful applicants will be responsible for
 
- Reviewing and updating the sterility protocols for a newly acquired packaging group in accordance to current medical device compliance regulations such as ISO 13485, ISO 9001 and FDA regulations.
- Investigation of non-conformity and CAPA related to sterilization and contamination, ensuring that reports are consistent and aligned with applicable standards.
- Creating and reviewing internal/external validation protocols respectively
 
Ideally you will hold a degree in Microbiology or similar relevant field and have experience of Sterilisation within a medical device/GMP environment. Basic knowledge of German is also desirable however is not an essential factor.

 

Contact:

To apply for this role please call 01925 851 469 or email your CV to Gareth.Gooley@labsupport.co.uk quoting reference number 2189301Lab Support is unable to employ any candidates requiring a sponsorship to work in the EU and all applicants must be in a position to accept employment without infringement of their immigration status. Lab Support is working as an Employment Agency in relation to this role.