Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.
This is a key role in the achievement of Jazz business objectives for the Jazz Development and Manufacturing facility. The QA/QMS specialist is a key member of the team tasked with successful day-to-day implementation of the Quality Management System (QMS) for the facility as well as supporting other organisational objectives. The QAQMS Specialist will be responsible for site document control, site training, operational and compliance support for manufacturing operations, inlcuding review and approval of associated manufacturing and testing records. In addition they will help maintain the site compliance program, supporting the supplier qualificiation and site self-inspection. The QA/QMS specialist will also represent quality on cross-functional and/or cross-company teams for business critical development projects.
- Impelment and oversee the quality systems ensuring compliance with all relevant regulatory guidelines and Jazz policies and strategies.
- SME and site owner for the site documentation system and the JazzLearn system.
- Manage the preparation, issue and control of GMP documents in the electronic Document Management System (EDMS) ensuring that required standards of presentation and formatting are consistently achieved.
- Collaboration with functional document owners to facilitate efficient processing of impacted documentation.
- Point of contact for training for the site, both for staff and for contract personnel.
- Liaise with managers to evaluate current skills profiles and training gaps and identify training requirements according to individual and team needs.
- File and archive training records as per site good documentation practices.
- Represent Quality during manufacturing operations and be available to resolve issues and provide guidance in a collaborative fashion.
- Provide quality and cGMP input and oversight of the manufacturing facility including data integrity.
- Review and approve procedures, documents and records (e.g. Specifications, Batch Records, Validation data, QC data, etc.) in accordance with the facility requirements.
- Review and approve technical support documentation. (Examples include cleaning, process, method validation).
- Generate and approve Quality documents (e.g. Annual Product Reviews, Licence variations etc.).
- Support the Deviation and OOS investigation systems, advising on assessing impact and approving final reports and associated CAPA.
- Support the site change control system, evaluating proposed change controls as assigned, making informed assessments of quality impact of changes.
- Support the facility Supplier Management program, including qualifications and re-qualifications of suppliers and materials, auditing vendors and providing oversight as required.
- Support site compliance program, performing internal audits, training internal auditors as required, and implementing audit action plans.
- Complete all required QMS assignments (CAPAs, investigations, actions etc) in accordance with agreed timelines.
- Perform production on the line AQLs, and the incoming inspection and disposition of raw materials, consumables, packaging
- Assist in preparation and presentation of GMP training programmes.
- Participate in initiatives and action plans for the development of QA and improvement of GMP compliance
- Involved in site-wide projects and continuous improvement processes.
Required Knowledge, Skills, and Abilities
- 2-5 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.
- 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.
- Posess good organizational skills and attention to detail.
- Posess good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
- Ability to handle and prioritize multiple assignments, changing priorities and meet deadlines.
- Experience in participation in regulatory audits (HPRA or FDA) desirable.
- QC analytical experience desirable.
- Computer skills i.e., Microsoft Office, Windows etc. Experience in Reliance, LIMS & SAP would be advantage
Required/Preferred Education and Licenses
- BSc in science discipline required.
Jazz Pharmaceuticals is an Equal Opportunity Employer.