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Job Description
Join Jazz Pharmaceuticals as a Senior Quality Assurance Specialist, where you'll play a vital role in overseeing quality in contract manufacturing and ensuring compliance with GXP standards. Your expertise will contribute to the development of life-changing medicines in a dynamic and supportive environment.
Key Responsibilities
Monitor quality performance of contract manufacturers and material suppliers
Perform batch review and disposition
Review and approve product complaints, deviations, validation protocols, and change controls
Conduct vendor audits and site visits
Assist in internal audits and regulatory agency inspections
Collaborate with contract manufacturers and testing labs to resolve quality issues
Summarize CMO Annual Product Quality Reviews
Maintain product related Quality Technical Agreements (QTAs)
Support the generation and improvement of department SOPs
Participate in regulatory inspection readiness
Required Qualifications
Strong knowledge of GMP and Regulatory Compliance in the Pharmaceutical/Biotechnology Industry
Ability to understand and apply GMP regulations related to manufacturing, QC analytical testing, and facility operations
Substantial experience in biologics drug substance manufacturing