Jazz Pharmaceuticals

Senior Quality Control Specialist

IE-Dublin
2 weeks ago(1/4/2018 11:56 AM)
ID
2018-3365
# of Openings
1
Category
Manufacturing

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 Director  Quality Control. Responsible for performing key Quality tasks in respect of Company products. Works in Quality Control within the Technical Operations department, which oversees contract manufacturing operations, select supply chain operations and development functions.

Responsibilities:

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
  • 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
  • Lead product trending programs for all products on 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).
  • Management of reference standard programs for all Jazz products
  • Ensure of compendial method updates implemented as appropriate for Jazz products

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

Professional Competencies:

  • Bachelor’s degree in chemistry, biology or a related discipline
  • At least 3-4 years’ experience working in a laboratory/quality environment with excellent knowledge of  cGMPs.
  • Experience in finished product pharmaceuticals / biologics/ APIs  
  • Experience with analytical investigations, change control and documentation management
  • 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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