Posted: 5 February
Offer description
Sterilization Leadership Role
Job Description:
The successful Sterilization Manager will be responsible for ensuring compliance with applicable corporate and divisional policies, procedures, and regulatory requirements. This role involves providing strategic leadership to sterilization processes, validations, and investigations throughout the product lifecycle.
Key Responsibilities:
1. Lead a team responsible for sterilization qualification of new products and changes to existing products.
2. Oversee sterilization validation activities for radiation-sterilized products, including dose setting and quarterly dose audits.
3. Manage sterilization validation activities for ethylene oxide (EO) sterilized products, including new product qualification, annual revalidations, EO residual studies, and D-value studies.
4. Promote technical expertise as the primary Sterilization Subject Matter Expert (SME), offering support to Product Development and Operations teams.
5. Collaborate in Supplier Quality audits of contract sterilization facilities and third-party manufacturers on behalf of your organization's production processes.
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