Quality Control Specialist

4w4 weeks ago

Jazz Pharmaceuticals

IE · Full-time · €50,000 – €65,000

About this role

Reporting to the Director of Quality Control/QA Commercial External Manufacturing, this role provides support for all aspects of QC operations for APIs, Drug Substance & Drug Product, ensuring compliance with regulatory guidelines and GMP standards. It collaborates with business partners to meet quality goals and patient supply.

Day-to-day responsibilities include managing stability programs for assigned products, supporting resolution of OOS/OOT analytical deviations, and providing analytical/technical support to Jazz Technical Operations and External Manufacturing. The specialist also leads analytical method transfers and validation programs.

The specialist operates Jazz CAPA, deviation, training, and compliance systems, and authors, reviews, and approves SOPs, analytical validation protocols, and reports. They build relationships with suppliers and contract manufacturers, maintain Quality Technical Agreements, and participate in business meetings as required.

Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for people with serious diseases. The company has a diverse portfolio of marketed medicines and a robust pipeline of innovative therapeutics. This role supports the creation and maintenance of regional and global quality control systems.

Requirements

Knowledge of cGMP standards and regulatory guidelines.
Experience managing stability programs for pharmaceutical products.
Experience leading analytical method transfers and validation programs.
Ability to troubleshoot analytical methods.
Experience operating CAPA, deviation, training, and compliance systems.
Ability to author, review, and approve SOPs, analytical validation protocols, and reports.
Experience providing analytical/technical support to manufacturing operations.

Responsibilities

Manage stability programs for assigned products in External Manufacturing Operations.
Support resolution of out-of-specification (OOS) and out-of-trend (OOT) analytical deviations.
Provide analytical/technical support to Jazz Technical Operations and External Manufacturing.
Ensure that operations within External Manufacturing and contract testing laboratories are compliant with cGMPs and regulatory filings.
Lead analytical method transfers and validation programs in compliance with regulatory and Jazz requirements.
Troubleshoot analytical methods.
Operate Jazz CAPA, deviation, training, and compliance systems.
Author, review, and approve SOPs, analytical validation protocols, and reports.

Benefits

Purpose-driven work: innovate to transform the lives of patients and their families.
Patient-focused and science-driven environment.
Opportunity to work with a diverse portfolio of marketed medicines and a robust pipeline of innovative therapeutics.