Sterility Assurance Manager

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Sterility Assurance Manager, Italia/Toscana

Location:

Not specified

Job Category:

Other

EU work permit required:

Yes

Job Reference:

542882877

Job Views:

1

Posted:

23.03.2025

Expiry Date:

07.05.2025

Job Description:

For our client, a leading pharmaceutical company, we are looking for:

Sterility Assurance Manager

The role will report directly to the Associate Director of Sterility Assurance and will oversee the daily activities of the Sterility Assurance team supporting the operations.

Responsibilities

• Manage and develop the assigned team
• Manage technical troubleshooting for non-conformities arising from day-to-day activities
• Ensure the implementation of the Sterility Assurance program, managing the timely preparation/revision of protocols and ensuring proper execution in terms of operations, documentation, and data integrity requirements
• Ensure coordination with operations, utilities, and micro-labs for sterility assurance-related activities (e.g., APS, Bioburden)
• Maintain Sterility Assurance excellence in the field
• Work in cross functional team and ensure effective communication is maintained between departments
• Support the preparation for regulatory inspections and ensure readiness, contributing to the site inspection program

• Master’s Degree in a scientific field (Pharma, Biotech, Microbiology preferred)
• Experience and good knowledge of aseptic process and Sterility Assurance
• Previous experience as people manager
• Fluent in English