Quality Assurance Specialist Role at Jazz Pharmaceuticals, Italy
Jazz Pharmaceuticals is hiring a Quality Assurance Specialist in Villa Guardia, Italy. This role plays a vital part in maintaining and enhancing the company’s quality systems while ensuring compliance with GMP standards. If you’re passionate about quality assurance and want to be part of Jazz Pharmaceuticals careers, this opportunity is perfect for you.
Job Details:
- Location: Villa Guardia, Como, Italy
- Req ID: R010494
- Category: Technical Operations
- Active contribution to the maintenance and improvement of the Quality System.
- Oversight of CMO activities for Drug Products.
- Conduct investigations for deviations and implement corrective/preventive actions (CAPAs).
- Ensure customer complaints and supplier issues are properly managed.
- Collaborate with internal departments and CMOs on manufacturing and change management.
- Review and approve batch production records, SOPs, and GMP documents.
- Conduct self-inspections and support client/regulatory audits.
- Embrace continuous improvement and Operational Excellence culture.
About Jazz Pharmaceuticals:
Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for patients with serious diseases. With a diverse portfolio in sleep disorders, epilepsy, oncology, and neuroscience, Jazz combines patient-focused innovation with pioneering research. The company is headquartered in Dublin, Ireland, with research, manufacturing, and employees worldwide committed to improving lives. Explore more Quality Assurance jobs.
Educational Requirements for Quality Assurance Specialist Role:
- Bachelor’s or higher degree in a life sciences subject.
- Experience in a quality assurance role at a pharmaceutical manufacturing site.
- Fluent in Italian and English.
- Preferred: Authorization as QP under European Directive 2001/83/EC and Italian regulatory requirements.
Key Responsibilities for Quality Assurance Specialist Role:
- Implement and maintain Quality Management System processes.
- Conduct deviation investigations and manage CAPAs.
- Ensure SOP compliance and review technical documents.
- Monitor batch production records for completeness and accuracy.
- Manage documentation, including Batch Records, CoAs, and Training Records.
- Support audits, inspections, and self-inspections.
- Evaluate and implement changes in compliance with regulations.
- Follow Environmental, Health, Safety, and Pharmacovigilance policies.
Skills Required for Quality Assurance Specialist Role:
- Expertise in Quality Management Systems: Documentation, Training, Supplier Qualification, Complaints, Deviations, CAPAs, Change Control, Audits.
- Strong knowledge of regulatory requirements and GMP compliance.
- Excellent technical writing skills (SOPs, protocols, reports).
- Ability to work independently and collaboratively in a team environment.
- Commitment to continuous improvement and operational excellence.
Benefits of the Quality Assurance Specialist Role:
- Medical, dental, and vision insurance.
- Retirement savings plan.
- Flexible paid vacation.
- Professional growth and global exposure through Jazz Pharmaceuticals careers.
