Jazz Pharmaceuticals

  • Quality Assurance Specialist

    Job Post Information* : Posted Date 4 months ago(4 months ago)
    # of Openings
    Min. Exp. (Yrs)
    Advertised Location : Location
    Job Post Information* : External Company Name
    Jazz Pharmaceuticals
    Job Post Information* : External Company URL
    Advertised Location : Address
    Waterloo Exchange
    Advertised Location : Postal Code
  • Overview

    Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

    Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

    We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals. 

    Position Profile

    This opportunity is available in Dublin, Ireland.

    Reporting the Quality Systems Manager. Responsilble for performaing key Quality tasks in respect of Company products. Work in the Quality Group within the Technical Operations department, which oversees contract manufacturing operations, select supply chain operations and development functions. Responsible for performing key Quality tasks in respect of Company products and development projects.

    Essential Functions

    • Provide oversight and management of components of the Quality Management System (QMS), which consists of, but not limited to, change control, deviations, CAPAS, Complaints, documentation and vendor management
    • Is proactive in looking of continuous improvement opportunities within the QMS.
    • Be a key member of company audit team during regulatory or customer audits.
    • Implement and improve Quality System to realize the highest quality standards attainable for all activities conducted by the company.
    • Act as lead auditor in third party vendor audits, to include: GMP contract manufucturing, analytical testing, and storage locations when required to ensure compliance with Jazz requirements and country specific regulations
    • Compile and manage Quality Systems metrics

    Required Knowledge, Skills, and Abilities

    • Work directly with other key company departments to ensure compliance and productive working relationships
    • Work closely with other members of Technical Operations group to ensure delivery of key projects objectives and timelines
    • Contribute to management of the supplier approval programme and to maintenance of the external audit schedule
    • Assist with troubleshooting quality issues
    • Maintain appropriate Quality Technical Agreements with all GxP vendors

    Required/Preferred Education and Licenses

    • Bachelor's degree in chemistry, biology or a related discipline
    • Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas
    • Experience with Third party vendor auditing, out of spec investigations, change control
    • Thorough understanding of quality systems and cGMP's

    Description of Physical Demands

    • Responsibilities may require working outside of “normal” hours, in order to meet business demands.

    Jazz Pharmaceuticals is an Equal Opportunity Employer.


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