At Jazz Pharmaceuticals, our purpose is to innovate and transform the lives of patients and their families. We develop life-changing medicines for people with serious diseases, often with limited or no therapeutic options.
Job Title
Sterile Drug Product Quality Assurance Specialist
We are seeking a highly organized and detail-oriented Sterile Drug Product Quality Assurance Specialist to join our External Manufacturing Quality Group within the Technical Operations department.
Main Responsibilities
* Monitor and support the quality performance of contract manufacturing organizations and material suppliers to all applicable GXP standards.
* Review and approve product complaints, deviations, validation protocols, change controls, and lead product-related investigations.
* Ensure compliance of all respective contract manufacturers to both internal Jazz requirements and country-specific regulations.
* Collaborate with contract manufacturers, packagers, and testing laboratories to resolve any quality issues.
* Highlight any risks associated with maintaining supply of commercial drug products to all markets.
* Conduct vendor audits and vendor site visits as required.
* Assist in internal audits and regulatory agency inspections.
Requirements
* Strong knowledge of GMP and Regulatory Compliance as applicable to the Pharmaceutical/Biotechnology Industry.
* Ability to understand and apply GMP regulations as they relate to manufacturing, QC analytical testing, and facility operations.
* Substantial experience working in or directly supporting manufacturing within sterile drug product manufacturing site.
* Highly organized, with exceptional time management and prioritization.
* Excellent verbal and written communication skills.
Education and Licenses
Bachelor's degree in pharmacy, chemistry, biotechnology, biochemistry, microbiology, or a related discipline.