What are the responsibilities and job description for the Sterility Assurance Consultant position at Oxenham Group?
Our customer is looking for a Sterility Assurance Expert to support their remediation efforts around sterilization. This consultant will support the implementation and validation of new sterilization processes for EO. The ideal candidate has a strong microbiology background and is a subject matter expert for sterilization and contamination in medical device.
Responsibilities :
- Collaborate with suppliers and other departments to ensure compliance to all sterilization standards
- Create and finalize validation protocols and report ensuring they are clear, concise, and compliant to work instructions and standards.
- Work with HQ sterilization team to identify appropriate remediation efforts to ensure devices are safe
- Assist in sterile release, bioburden and dose audit, and environmental monitoring programs
- Strong knowledge of ISO 11137 and 11135 and applying it to the specific processes
Requirements :
