Jazz Pharmaceuticals

  • QC Manager

    Job Post Information* : Posted Date 2 months ago(9/26/2018 5:24 AM)
    ID
    2018-3665
    # of Openings
    1
    Min. Exp. (Yrs)
    8
    Category
    Manufacturing
    Advertised Location : Location
    IE-Dublin
    Job Post Information* : External Company Name
    Jazz Pharmaceuticals
    Job Post Information* : External Company URL
    https://www.jazzpharma.com/
    Advertised Location : Address
    Waterloo Exchange
    Advertised Location : Postal Code
    4
  • 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 to the Director , Quality Control the role will provide support for all aspects of commercial operations for APIs, Drug Products ensuring compliance with regulatory guidelines and GMP/quality standards..  Through collaboration with business partners the individual in this role ensures that QC support is provided to meet commercial objectives, supply chain requirements and ensures successful outcomes from interactions with Health Authorities, including inspections, regulatory filings and meetings.  The Manager of Quality Control ensures that appropriate oversight and direction is provided for QC testing at contract testing laboratories and contract manufacturing operations  Additional responsibilities will include cross-functional team membership..

    Responsible for developing and maintaining functions of Quality Control and ensures that all activities are fully in compliance with cGMP standards.

    The individual is responsible for, but is not limited to:

    • Management of stability programs for all Jazz products
    • Lead out-of-specification (OOS)/out of trends (OOT) analytical deviations
    • Provide analytical/technical support to Jazz Technical Operations and CMOs
    • Ensure that operations within CMOs and contract testing laboratories are compliant with cGMPs
    • Manage analytical method transfers/validation programs in compliance with regulatory/Jazz requirements
    • Troubleshooting of analytical methods
    • Operate Jazz CAPA/deviation, training and compliance systems
    • Develop and author SOPs, analytical validation protocols and reports.
    • Implement and improve Quality Systems to realize the highest quality standards attainable for all activities conducted by the company.
    • Report Quality Control Metrics
    • Product trending programs for all products at release and stability
    • Build authentic relationships and participate in business meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTA’s).
    • Support the creation and maintenance of regional and global quality control and laboratory systems in relation to quality control operation. Actively support QC system improvements to ensure efficient, effective and compliant process
    • Management of reference standard programs for all Jazz products
    • Ensure of compendial method updates implemented as appropriate for Jazz products
    • Ensure that budgets, cost and reporting on financials associated with commercial QC activities

    Other responsibilities:

    • Identify and implement Continuous Improvement programs as appropriate within Jazz
    • Work closely with other members of Jazz Technical Operations group and CMOs to ensure delivery of key project objectives
    • Assist with troubleshooting quality control issues at CMOs when required.
    • Maintain appropriate Quality Technical Agreements with all GxP vendors
    • Supporting regulatory submissions as required
    • This position may require up 15 % travel

    Professional Competencies:

    • Bachelors of Science, Masters or Ph.D degree in biochemistry, chemistry or a related discipline
    • At least 8-10 years’ experience working in a laboratory/quality environment within the pharmaceutical industry
    • Experience in finished product pharmaceuticals/biologics/APIs desirable
    • Demonstrated knowledge of quality systems, FDA and EU guidelines as the relate to analytical testing/product manufacturing
    • Experience with regulatory inspections and submission of regulatory filings
    • Strong Interpersonal skills and professional skills to interact at all levels including senior management, contractors, and colleagues
    • Excellent communication and time management skills

    Jazz Pharmaceuticals is an Equal Opportunity Employer.

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