If you are a current Jazz employee please apply via the Internal Career site
Jazz Pharmaceuticals is a global biopharma 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, 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. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.
Job Description
Essential Functions/Responsibilities
- Implement and oversee the quality systems ensuring compliance with all relevant regulatory guidelines and Jazz policies and strategies.
- 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.
- Generate QMS Standard Operating Procedures (SOPs) to reflect these processes, which are easy to follow and promote both compliance and efficient operations, in accordance with facility requirements.
- 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.
- 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.
- 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
- 3-7 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.
- 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.
- Possess 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.
- Demonstrated expertise in the area of Data Integrity highly desirable.
- Experience in participation in regulatory audits (HPRA or FDA) 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.
- Lead auditor certification highly 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: https://careers.jazzpharma.com/benefits