Jazz Pharmaceuticals

Senior Specialist Quality Systems

Job Locations IE-Dublin
Posted Date 1 month ago(1/17/2018 4:52 AM)
ID
2018-3380
# 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 the Technical Operations organisation based in Dublin. The position supports the Quality Systems group through the management of a unit of the Pharmaceutical Quality System as a System (Process) owner. Specifically, this role includes the management of GMP/GDP Quality Councils on a monthly basis, the Quality Management Review performed every 6 months and the provision of Quality metrics to support the compliance and continuous development of the organisation. The position will also perform a regulatory intelligence review for applicability Jazz Pharmaceuticals.

Responsibilities:

The position is responsible for developing and maintaining aspects of the Quality Systems and to ensure that all operations are fully in compliance with current international standards for GMP/GDP.

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

  • To manage and prepare for the routine GMP/GDP Quality Councils, from meeting and scheduling to agenda setting, generation of presentations, minute taking and CAPA generation.
  • To manage and prepare for the Quality Management Review meeting, scheduling to agenda setting, generation of presentations, minute taking and CAPA generation.
  • Compile and manage Quality Systems metrics, including those Quality Metrics presented at the GMP/GDP Quality Council meetings.
  • Generating monthly Quality Dashboard and continually review metrics to ensure meeting requirements. Evolve the current monthly Quality Dashboard into an interactive dashboard.
  • Ensure that all Quality Key Performance Indicators (KPI) are aligned across all Jazz Pharmaceutical sites as appropriate; assess KPI trends and communicate these to the relevant functions.
  • Perform a review of regulatory intelligence, peer reviews and advisory agencies publications for updates and changes that are applicable to Jazz Pharmaceuticals.
  • Assess the updates and changes to the regulations through performing gap analysis or risk assessments and communicate these to the relevant departments, including the use of change control to integrate these into the Jazz Pharmaceuticals systems.
  • Is proactive in looking for continuous improvement opportunities within the QMS.
  • Implement and improve Quality Systems to realize the highest quality standards attainable for all activities conducted by the company.
  • Create/Update SOPs, WI, Standards and forms.
  • Be a key member of company audits teams during regulatory or customer audits.
  • Build authentic relationships and participate in business meetings, as required, with internal stakeholders.

Other Responsibilities:

  • Work directly with other key Jazz Pharmaceuticals departments and Global GxP internal customers to ensure compliance and productive working relationships.
  • Work closely with other members of Technical Operations to generate meaningful data for metrics and to facilitate effective Quality Council meetings

Professional 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
  • Very good oral and written communication skills
  • Good experience of data analysis and presentation
  • Thorough understanding of quality systems and cGMP's
  • Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues

Jazz Pharmaceuticals is an Equal Opportunity Employer.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Connect With Us!