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    AL

    Alvotech

    Biotechnology

    Quality eSystem Specialist

    Reykjavik Headquarters, IcelandOn-SiteFull-timePosted 4d ago
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    Job description

    Scope and responsibility:

    • Provide Quality Systems expertise and support for GxP electronic systems across the organization.
    • Support the administration, configuration, maintenance, and continuous improvement of quality-related electronic systems, including Veeva Quality, Veeva LIMS, MasterControl, and other regulated platforms.
    • Design, create, verify, and maintain system master data and data structures to ensure data integrity and regulatory compliance.
    • Support implementation of new functionality, system enhancements, and introduction of new electronic solutions.
    • Execute and support system validation activities, including testing, verification, and User Acceptance Testing (UAT).
    • Support investigation, troubleshooting, and resolution of system-related issues in collaboration with business and technical stakeholders.
    • Participate in cross-functional projects focused on digitalization, process improvements, and quality system enhancements.

    Job requirements:

    • University degree in pharmacy, biotechnology, chemistry, biology, engineering, computer science, information systems, or a related field.
    • Experience working in the pharmaceutical, biotechnology, or other regulated industries is desired.
    • Experience supporting or administering GxP computerized systems.
    • Working knowledge of Quality Management Systems and GMP requirements.
    • Experience with systems such as Veeva, MasterControl, LIMS, SAP, or equivalent enterprise platforms is considered an advantage.
    • Understanding of computerized system validation principles and data integrity requirements is beneficial.
    • Excellent communication and team working skills.
    • Strong attention to detail and commitment to quality.
    • Proficient English skills are required.

    Job details are sourced from the employer's original posting.

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    About the company

    Alvotech

    Alvotech is a biopharmaceutical company focused on the development and manufacturing of biosimilar medicines. They aim to provide affordable and accessible biologic treatments to patients worldwide.

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    Industry
    Biotechnology
    Open roles
    7

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