Jazz Pharmaceuticals is a global biopharma company that transforms lives of patients and their families by developing life-changing medicines for serious diseases.
We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience.
The Senior QA Specialist is a key member of the team responsible for successful day-to-day running of Quality Operations and Quality Management System (QMS) for the facility. This role will support other organisational objectives, represent quality on cross-functional and/or cross-company teams, and manage supplier qualification program.
Key Responsibilities
* Represent Quality during manufacturing operations and provide guidance in a collaborative fashion.
* Ensure manufacture of quality products in accordance with product licenses and filings.
* Perform production AQLs, incoming inspection and disposition of raw materials, consumables, packaging.
* Review and implement manufacturing related documents.
* Implement and oversee quality systems to ensure compliance with regulatory guidelines and Jazz policies.
* Provide quality and cGMP input and oversight of the manufacturing facility.
* Manage and support Supplier Management program, including qualifications and re-qualifications of suppliers and materials.
* Generate Quality Systems metrics and prepare presentations suitable for Senior Management review.
* Generate and approve Quality documents.
* Support validation activities and review technical support documentation.
* Manage QMS system to ensure compliance and adherence to site metrics.
* Manage QA responsibilities of external manufacturers of APIs.
* Support site compliance program and participate in third-party audits and inspections.
* Partner with other SMEs to understand changes in the regulatory environment and coordinate quality involvement.
* Lead and support initiatives for QA improvement and GMP compliance.
* Lead and support site-wide projects and continuous improvement processes.
Requirements
* 4-7 years' experience in finished product pharmaceutical/biologics manufacturing.
* Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs and ICH guidelines.
* Highly flexible, works well in a team environment, and has necessary skills to organize, communicate, influence and lead.
* Demonstrated capability in establishing collaborative working relationships at all levels.
* Possess fundamental scientific thought processes and ability to apply this to overcome problems.
* Recognize areas for improvement and use initiative to implement change programs.
* Ability to work independently, as well as a member of a team in a dynamic environment.
* Ability to deliver objectives on time, every time, while meeting all compliance and cost targets.
* Ability to generate documentation which is of a high standard.
Education and Licenses
* BSc in science discipline required.
* Lead auditor certification highly desirable.
* Qualified Person experience or educational requirements desirable.