Senior QA Specialist
Category: Manufacturing | Country: Ireland | City: Dublin | Type: Regular, Full Time | Job ID: 4158
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.
Reporting to the Associate Director Quality Assurance. Responsible for performing key Quality tasks in respect of Company products. Work in the Quality Group within the Technical Operations department, which oversees contract manufacturing operations, select supply chain operations and development functions.
Specifically, this position is responsible for Quality oversight of CMOs/vendors of Jazz Investigational Medicinal Product, used in Jazz sponsored clinical studies in support of new product introduction and existing product development during lifecycle management.
The individual is responsible for, but is not limited to:
- Monitor the operations at the Contract Manufacturer. Perform batch review, review product complaints, deviations, change controls and product related investigations.
- QA oversight and management of out-of-specification (OOS) investigations, deviations and CAPAs
- Managing the product stability programme
- Act as lead auditor in third-party vendor audits, to include: GMP contract manufacturing, analytical testing, and storage locations when required to ensure compliance with Jazz requirements and country-specific regulations.
- Be a key member of company audit team during regulatory or customer audits.
- Develop and write SOPs & controlled documents as required.
- Review and approval of product artwork/labelling
- Build authentic relationships and participate in business meetings, as required, with suppliers and contract manufacturers and maintain all product-related, Quality Technical Agreements (QTAs).
- Implement and improve Quality Systems to realize the highest quality standards attainable for all activities conducted by the company.
- Report Quality Metrics
- Work directly with other key Company departments to ensure compliance and productive working relationships.
- Work closely with other members of Technical Operations group to ensure delivery of key project objectives and timelines
- Contribute to management of the supplier approval programme and to maintenance of the external audit schedule.
- Assist with troubleshooting quality issues at Partner’s or vendor’s site or associated with technology transfer, when required.
- Maintain appropriate Quality Technical Agreements with all GxP vendors
- Supporting regulatory submissions
- Bachelor’s degree in chemistry, biology or a related discipline
- Experience working in finished product pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas
- Experience with third party vendor auditing, out of spec investigations, change control
- Thorough understanding of quality systems and cGMP’s, experience with phase appropriate GMPs desirable
- Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues
- Experience working with contract manufacturing
- Experience interfacing with regulatory bodies or working on regulatory submissions
Jazz Pharmaceuticals is an Equal Opportunity Employer.