Sr QA Specialist

Jazz Pharmaceuticals
IE - Ireland Site Based
December 31, 2024

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit *** and follow @JazzPharma on Twitter.

The Senior QA specialist is a key member of the team tasked with successful day-to-day running of the Quality Operations and Quality Management System (QMS) for the facility as well as supporting other organisational objectives. The Senior QA Specialist will be responsible for operational and compliance support for manufacturing operations, maintain the site compliance program, and manage the supplier qualification program. The Senior QA specialist will also represent quality on cross-functional and/or cross-company teams for business-critical development projects.

Essential Functions/Responsibilities

Represent Quality during manufacturing operations and be available to resolve issues and provide guidance in a collaborative fashion.
Represent and provide operational quality support for production, ensuring the manufacture of quality products in accordance with product licences and filings.
Perform production on the line AQLs, and the incoming inspection and disposition of raw materials, consumables, packaging.
Review and manufacturing related documents (e.g. Specifications, Batch Records, Validation data, QC data, etc.) in accordance with the facility requirements.
Implement and oversee the quality systems (change controls, deviations etc.) ensuring compliance with all relevant regulatory guidelines and Jazz policies and strategies.
Provide quality and cGMP input and oversight of the manufacturing facility including data integrity.
Manage and support the facility Supplier Management program, including qualifications and re-qualifications of suppliers and materials, auditing vendors and providing oversight as required, ensuring all Quality Technical Agreements are managed and in compliance.
Generate Quality Systems metrics and prepare presentations suitable for Senior Management review.
Generate and approve Quality documents (e.g. Annual Product Reviews, Licence variations etc.).
Support validation activities. Review and approve technical support documentation. (Examples include cleaning, process, method validation).
Manage a QMS system to ensure compliance and adherance to the site metrics, including representing the site on the global QMS teams.
Manage the QA responsibilities of external manufacturers of APIs, reviewing deviations and changes at the CMO site.
Support site compliance program, performing internal audits, training internal auditors as required, and implementing audit action plans.
Participate and follow-up in third party audits and/or inspections carried out at the site by the authorities or clients.
Partner with other Jazz SMEs to understand and proactively respond to changes in the regulatory environment and coordinate quality involvement as required
Lead and support initiatives and action plans for the development of QA and improvement of GMP compliance
Lead and support site-wide projects and continuous improvement processes.

Required Knowledge, Skills, and Abilities

4 - 7 years' experience working in finished product pharmaceutical / biologics manufacturing, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
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, regardless of seniority.
Possess fundamental scientific thought processes and demonstrated ability to apply this to overcome problems. An ability to think strategically and be a 'go-to' expert across the business in area of expertise.
Recognize areas for improvement and use initiative to implement change programs in support of progress.
Ability to work independently, as well as a member of a team in a dynamic, fast-paced 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.

Possess good organizational skills and attention to detail.
Ability to handle and prioritize multiple assignments, changing priorities and meet deadlines.

Demonstrated expertise in the area of Data Integrity highly desirable.
Working experience in SAP and LIMS highly desirable.
Experience in participation in regulatory audits (HPRA or FDA) desirable.

Required/Preferred Education and Licenses

BSc in science discipline required.
Lead auditor certification highly desirable.
Qualified Person experience or educational requirements desirable.

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: ***/benefits.html.

Read the full job description and apply online on the recuiter's web-site

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