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    • Sterility Assurance Manager - Toscana - Pharma Point Srl

    Pharma Point Srl
    Pharma Point Srl Toscana

    1 mese fa

    Default job background
    Gestione superiore / Consulenza
    Descrizione

    For our client, a leading pharmaceutical company, we are seeking an experienced professional to fill the role of Sterility Assurance Manager.

    Sterility Assurance Manager

    This position reports directly to the Associate Director of Sterility Assurance and is responsible for overseeing the daily activities of the Sterility Assurance team supporting operations.

    Key Responsibilities:

    • Manage and develop a team of professionals to ensure the effective execution of sterility assurance protocols.
    • Lead technical troubleshooting efforts for non-conformities arising from day-to-day activities, ensuring timely resolution and minimal disruption to operations.
    • Develop and implement the Sterility Assurance program, managing the preparation and revision of protocols, and ensuring adherence to operational, documentation, and data integrity requirements.
    • Coordinate with operations, utilities, and micro-labs for sterility assurance-related activities, such as APS and bioburden testing.
    • Maintain and promote sterility assurance excellence within the organization.
    • Collaborate with cross-functional teams and ensure effective communication between departments.
    • Support the preparation for regulatory inspections, contributing to the site inspection program and ensuring readiness.

    Requirements:

    • Master's degree in a scientific field (pharmaceuticals, biotechnology, or microbiology preferred).
    • Experience and strong knowledge of aseptic processes and sterility assurance principles.
    • Proven track record as a people manager, with experience leading high-performing teams.
    • Fluency in English language, both written and spoken.
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