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    Quality Assurance Senior Technologist - Oxford, Oxfordshire, United Kingdom - Jazz Pharmaceutical

    Jazz Pharmaceutical
    Jazz Pharmaceutical Oxford, Oxfordshire, United Kingdom

    2 weeks ago

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    Description
    If you are a Jazz employee please apply via the Internal Career site Jazz Pharmaceuticals plc (


    NASDAQ:

    We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options.

    We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology.

    We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies.

    Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and follow @JazzPharma on Twitter.

    Prepare, perform, report and follow-up independent clinical quality assurance audits including associated quality management activities and provide input into the audit schedule.

    To support Clinical Quality Assurance in its application and development of the Quality Management System and provide expert regulatory guidance and quality support to functional departments involved in all aspects of clinical trials.

    Competent and experienced senior auditor for GCP and PV (related to clinical studies).
    Support the implementation of the global quality management system.

    To understand and apply appropriate guidelines and regulations, including ICH, FDA, MHRA and EMA and other worldwide regulations, in a risk-based manner to Clinical Studies/Trials, including Pharmacovigilance activities and quality vendor management.

    CQA Quality Lead for Clinical Quality Assurance to support Study teams, providing quality support and regulatory requirements advice/guidance for multiple clinical studies/trials.

    Create and Manage Study Quality Oversight and Audit Plans.
    Conduct Study Quality Reviews and assess/verify GCP Statements.
    To assist with the preparation for GCP/GPvP inspection readiness and supporting inspections by national and international regulatory bodies at Jazz and Investigator Sites

    To report quality issues or non-compliance to the Associate Director CQA and client groups, where appropriate, that are detected whilst carrying out duties for GCP, and other relevant GxP activities.

    To review and assess quality issues or non-compliances and associated corrective and preventative actions to ensure the investigation and actions implemented were appropriate and risk-based in accordance with applicable guidelines and regulations, including ICH, FDA, MHRA, EMA and other worldwide regulations.

    To assist the Associate Director CQA with the promotion of quality awareness among Jazz, vendors and investigator site personnel.

    Typically, 5+ years relevant work experience in the Pharmaceutical, Biotechnology or a related industry
    Demonstrable QA compliance experience and an understanding of applicable GCP regulations and guidelines and some working knowledge of pharmacovigilance regulations and guidelines
    ~ Knowledge and experience of working to pharmaceutical regulatory standards in clinical research.

    Working knowledge of office IT packages
    Understands risk within clinical trials and is able to apply a risk-based approach to both clinical studies and CQA activities
    Understands and can demonstrate the principles of quality by design in relation to clinical trials
    not fearful of acting with a minimum of planning; is excellent at honest analysis; Bachelor's degree in science or related discipline
    Post-graduate qualifications (Master's, PhD) preferred
    Jazz Pharmaceuticals is an Equal Opportunity Employer.
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