Jazz Pharmaceuticals

  • QA Lead

    Job Post Information* : Posted Date 3 weeks ago(8/2/2018 9:48 AM)
    ID
    2018-3717
    # of Openings
    1
    Min. Exp. (Yrs)
    5
    Category
    Manufacturing
    Advertised Location : Location
    IE-Roscommon-Athlone
    Job Post Information* : External Company Name
    Jazz Pharmaceuticals
    Job Post Information* : External Company URL
    https://www.jazzpharma.com/
    Advertised Location : Address
    Jazz Pharmaceuticals
  • 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

    Reporting to the Senior Manager QA and QP, the QA Lead is a key member of the team tasked with oversight and implementation of the Quality Management System (QMS) and Operational Quality Support for the facility. In this role the QA Lead will oversee the quality support to manufacturing operations as well as supporting other organisational objectives.

    Essential Functions

    • Implement and oversee site quality systems ensuring compliance with all relevant regulatory guidelines and Jazz policies and strategies.
    • Oversee operational quality support for production, ensuring the manufacture of quality products in accordance with product licences and filings.
    • Represent Quality during manufacturing operations and be available to resolve issues and provide guidance in a collaborative fashion.
    • Prepare batch records and associated documentation for batch certification.
    • Review and approve procedures, documents and records (e.g. Specifications, Batch Records, Validation data, QC data, etc.) in accordance with the facility requirements.
    • Review and approve technical support documentation. (Examples include cleaning, process, method validation).
    • Partner with other Jazz SMEs to understand and proactively respond to changes in the regulatory environment and coordinate quality involvement as required.
    • Maintain the QMS to ensure compliance, Develop and manage the site quality metrics and report KPIs to monitor site quality metrics performance.
    • Support the Deviation and OOS investigation systems, advising on assessing impact and approving final reports and associated CAPA.
    • Support the site change control system, evaluating proposed change controls as assigned, making informed assessments of quality impact of changes.
    • Generate and approve Quality documents (e.g. Annual Product Reviews, Licence variations etc.).
    • Support site compliance program, performing internal audits, training internal auditors as required, and implementing audit action plans.
    • Complete all required QMS assignments (CAPAs, investigations, actions etc) in accordance with agreed timelines.
    • Review and approval of Product artwork.
    • Assist in preparation and presentation of GMP training programmes.
    • Participate in initiatives and action plans for the development of QA and improvement of GMP compliance
    • Involved in site-wide projects and continuous improvement processes.

    Required Knowledge, Skills, and Abilities

    • 7-10 years’ experience working in finished product pharmaceutical / biologics manufacturing, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
    • Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs and ICH guidelines.
    • Highly flexible, works well in a team environment, and has necessary skills to organize, communicate, influence and lead.
    • Demonstrated capability in establishing collaborative working relationships at all levels, regardless of seniority
    • Possess fundamental scientific thought processes and demonstrated ability to apply this to overcome problems
    • Recognize areas for improvement, and use initiative to implement change programs in support of progress
    • Ability to deliver objectives on time, every time, while meeting all compliance and cost targets
    • Ability to generate documentation which is of a high standard.
    • Possess good organizational skills and attention to detail.
    • Ability to handle and prioritize multiple assignments, changing priorities and meet deadlines.
    • Through leading by example, cultivate and nurture culture of collaboration and participation among the team.
    • Foster a culture of change, innovation and self-improvement to maximise achievement of overall site goals
    • Generate documentation which  is of a high standard
    • Demonstrated expertise in the area of Data Integrity highly desirable.
    • Strong Validation experience desirable.
    • Experience in participation in regulatory audits (HPRA or FDA) desirable.
    • QC analytical experience desirable.

    Required/Preferred Education and Licenses

    • BSc/MSc in science discipline required.
    • Lead auditor certification highly desirable.
    • Qualified Person experience or educational requirements desirable

    Jazz Pharmaceuticals is an Equal Opportunity Employer.

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