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Jazz Pharmaceuticals

Senior Associate Quality Assurance Specialist (12 Month Fixed Term Contract)

UK - Site-Based - Kent Science Park
Posted 29 days ago
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Job Description

About the Role:

To assist the Quality Compliance Manager and other QA team members in the implementation of the Quality Systems at the KSP facility and associated contractor sites.

Key Responsibilities:

  • Managing and maintaining of the quality management system:
    • Corrective and preventative actions (CAPA)
    • Deviations
    • Change control
    • Supplier and customer complaints
    • Quality risk management (QRM)
    • Leading root cause analysis (RCA)
    • Liaising with global process owners to ensure consistency in the QMS between sites and functions
    • Training in the QMS
    • Collating QMS metrics and KPI data
    • Presenting QMS data at quality management review (QMR) meetings

Detailed Responsibilities:

  • Prepares, reviews, updates, and completes QMS processes
  • Ensures training records are kept up to date
  • Carries out their work in a way that will not adversely affect their own, or others’ health, safety, and security or the environment and reports any shortcomings in GW arrangements
  • Ensures all complaints are documented, investigated, and closed out within agreed guidelines. Escalates issues as required
  • Strives to ensure quality events are closed within agreed timeframes and facilitates management of quality events across KSP
  • Assisting in the assembly of the product quality review
  • Ensuring that regulatory, marketing partners due diligence, and other audits/inspections performed at GW are supported with efficient document retrieval and supply of the technical information
  • Assists in the creation of technical agreements, supplier agreements, and quality risk assessments
  • Participates or leads projects to deliver improvements in productivity and efficiency in all areas relevant to complaints
  • Authors and reviews all required quality documents
  • Creates training packages for QMS process at KSP
  • Authors and edits SOPs associated with the QMS at KSP

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Essential Skills:

  • Knowledge:
    • Typically, Bachelor’s degree in science or related discipline
    • Post-graduate qualifications (Master’s, PhD) preferred
  • Experience:
    • Minimum 3 years relevant work experience in the Pharmaceutical, Biotechnology, or a related industry
    • Experience working within a quality environment, including experience in GMP, GACP, and GDP
  • Skills:
    • Working knowledge of office IT packages
    • High level of written and verbal communication skills

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About the Company:

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental, and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits

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Location

Kent, England, United Kingdom

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