Jazz Pharmaceuticals

Senior Licenses Specialist, Quality Systems

Job Locations IE-Dublin
Posted Date 2 weeks ago(2/12/2018 8:23 AM)
ID
2018-3421
# 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

This position is part of the Quality Systems group within Technical Operations organisation based in Dublin. The position supports the application for and ongoing maintenance of all licenses at the Dublin site, currently comprising of WDA, MIA (IMP) and MIA (Commercial). The role will also include responsibilities associated with GDP activity, including product distribution, returns and serialisation. This position will also support the Affiliate network licenses.

Responsibilities:

  • Maintaining, budgeting and updating the licenses against the Jazz Pharmaceuticals Dublin location
  • Coordinating contact with the relevant Health Authority (HA) with respect to licensing issues
  • Acting as SME and for Health Authorities during an inspection against the licenses
  • Support local licenses throughout global affiliate network through technical support
  • Ensuring ongoing license compliance through Inspection Readiness projects
  • Act as GDP expert providing global support, as required, in current and future projects
  • To support, and where required take part in, GDP Audits to support local and global license compliance
  • To generate and maintain Quality  Technical Agreements for GDP and affiliate contractors
  • To participate in continuous improvement projects utilising Operational Excellence programs

Other Responsibilities: standardise with other role

  • Work directly with other key Jazz Pharmaceutical departments to ensure compliance and productive working relationships.
  • Work closely with other members of Technical Operations  organization to ensure delivery of key project objectives and timelines
  • Contribute to management of the supplier approval program through audit participation and GDP compliance oversight
  • Assist with troubleshooting quality issues at partner sites, when required.
  • Supporting regulatory submissions to ensure impacted licenses are maintained in compliance

Personal Competencies:

  • Bachelor's degree in. chemistry, biology or a related discipline
  • Experience working in finished product pharmaceutical/ biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas
  • Experience with third party vendor auditing, complaint handling and change control
  • Thorough understanding of quality systems and GMP/GDP
  • Very good oral and written communication skills
  • Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues
  • Experience working with contract manufacturing
  • Lead auditor training and experience
  • Experience interfacing with regulatory bodies or supporting regulatory submissions

Jazz Pharmaceuticals is an Equal Opportunity Employer.

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