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    • Sterility Assurance Manager - Toscana - Pharma Point

    Pharma Point
    Pharma Point Toscana

    1 mese fa

    Default job background
    Descrizione

    Summary of Job Description:

    The position of Sterility Assurance Manager is a key role in the operations of our client, a leading pharmaceutical company. This individual will oversee the daily activities of the Sterility Assurance team and be responsible for ensuring sterility assurance excellence in the field.

    Job Description

    The Sterility Assurance Manager will report directly to the Associate Director of Sterility Assurance and be responsible for managing and developing the assigned team. Key responsibilities include:

    1. Team Management

      2. Manage and develop the assigned team to ensure effective execution of sterility assurance-related activities.

    2. Troubleshooting and Technical Support

      3. Manage technical troubleshooting for non-conformities arising from day-to-day activities.

    3. Sterility Assurance Program Implementation

      4. Ensure the implementation of the Sterility Assurance program, including the timely preparation/revision of protocols and proper execution in terms of operations, documentation, and data integrity requirements.

    4. Cross-Functional Team Collaboration

      5. Coordinate with operations, utilities, and micro-labs for sterility assurance-related activities (e.g., APS, Bioburden).

    5. Regulatory Readiness

      6. Support the preparation for regulatory inspections and ensure readiness, contributing to the site inspection program.

    Requirements

    To be successful in this role, candidates must possess the following qualifications:

    1. Education

      2. A Master's Degree in a scientific field (Pharma, Biotech, Microbiology preferred).

    2. Experience

      3. Good knowledge of aseptic process and Sterility Assurance, as well as previous experience as a people manager.

    Employment Details

    This is a full-time position at a mid-senior level within the Quality Assurance and Engineering department of the Pharmaceutical Manufacturing industry.

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