Job Description

Sterilisation Manager
Our client, a global healthcare organisation are currently recruiting for a Sterilisation Manager for their medical device manufacturing and R&D site. As Sterilisation Manager you will be responsible for leading sterilisation activities in compliance with applicable quality systems, regulatory requirements, and internal policies. You will provide technical leadership and subject matter expertise across sterilisation validation, qualification and ongoing compliance.

Responsibilities

  • Lead a team responsible for sterilisation qualification for new products and changes to existing products
  • Manage radiation sterilisation validation, including dose setting and routine dose audits
  • Oversee ethylene oxide (EO) sterilisation validation, including new product qualification, annual revalidation, EO residual studies and D-value studies
  • Act as Sterilisation Subject Matter Expert, supporting Product Developmen...

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