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  • Sterility Assurance Coordinator - Firenze - Lilly

    Lilly
    Lilly Firenze

    2 settimane fa

    Default job background
    Descrizione

    At Lilly, we unite caring with discovery to make life better for people around the world.

    We are a global healthcare leader headquartered in Indianapolis, Indiana.

    About Us

    Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

    We put people first and give our best effort to our work.

    The Role

    The Sterility Assurance Coordinator will be a key member of the Sterility Assurance Team.

    This person will coordinate the primary loop agenda, including planning, execution, monitoring, and problem-solving on the field.

    The goal is to maintain a sustainable e-functional organization that ensures business continuity and alignment within parenteral lines.

    This role will also guarantee the coordination and implementation of projects from the Parenteral Network alignment streams and key changes on the line impacting sterility assurance strategy.

    The Sterility Assurance Coordinator will report directly to the Sterility Assurance Associate Director.

    This person will manage the activities of the Sterility Assurance Scientist supporting the primary loop daily.

    The resource will provide continuous support on the line as a backup of the primary loop sterility assurance representatives.

    This individual will be a Flow team member (cross-functional team) to ensure integrated governance and lean communication flow.

    Key Responsibilities

    1. Speed up technical troubleshooting of non-conformities emerged from day-to-day activities
    2. Ensure Sterility Assurance program execution
    3. Manage in a timely routine protocols preparation/revision and ensure the right execution in terms of operations, documentation, and data integrity requirements
    4. Manage and coordinate small/urgent improvement projects (e.g. EM bag shortage, new gloves supplier)
    5. Process monitoring (site Sterility Assurance metrics, sharing EM report with field)
    6. Guarantee coordination with operations/utilities/bio lab for activities concerning sterility assurance involvement (e.g. APS, EM sampling for EMPQ, Utilities related activities)
    7. Alignment of the Sterility Assurance aseptic technique between modules
    8. Maintain Sterility Assurance Excellence on the field

    This person is responsible for performing the Sterility Assurance, supporting the preparation and ensuring readiness for any Regulatory inspection, and supporting the site inspection program.

    Coordinate and back up the Sterility Assurance Process Team member.

    Share the mission, vision of the company, and site objectives with collaborators.

    Ensure effective communication is maintained between the primary loop and secondary loop.

    Develops technical and relational skills of the collaborators.

    Couch Tier 1.

    Requirements

    • Master's Degree (Scientific) Pharma, Biotech, and Microbiology Field preferred
    • Advanced knowledge of English (at least B2 CEFR)
    • Very good Knowledge of aseptic processes and Sterility Assurance concepts
    • Very good knowledge of current GMPs, pharmaceutical legislation, and regulatory requirements
    • Strong interpersonal skills and attitude toward people management (team orientation, personnel development, etc)
    • Relevant experience within the Process Team (Operation PT, LAB PT)
    • Minimum of 4 years of relevant experience in the pharmaceutical parenteral industry

    What We Offer

    Step into a role where your expertise is recognized, appreciated, and rewarded.

    As a member of our team, you can expect:

    • Competitive Salary: We offer a competitive base salary supplemented by an annual variable component based on achieving objectives
    • Relocation Package: You will be eligible for a relocation package based on your location
    • Comprehensive Benefits: Enjoy a well-rounded welfare package, including an extensive insurance plan
    • Annual Salary Review: We recognize and reward your continued effort with an annual salary review, providing opportunities for advancement based on your performance

Offerte di lavoro
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Florence