PbIf you are a current Jazz employee please apply via the Internal Career site. /b /p pJazz 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 for more information. /p ppbBrief Description: /b /ppActive contribution to maintenance and improvement of the Quality System at the Manufacturing site and overview of the CMO activities for Drug Product /ppbEssential Functions/Responsibilities /b /pulliConducts proper binvestigations /b in case of deviations and appoints the required personnel for an effective root-cause analysis and proper definition of suitable corrective/preventive actions. /liliDefines and verifies bCorrective / Preventive Actions /b following investigations. /liliVerifies the bapplication /bof the Company Quality System (eg. SOPs application, Quality Agreements) by both GMP related relevant departments and external personnel. /liliMakes sure that bcomplaints /b from customers and to suppliers are recorded and managed according to Company’s SOP and appoints the required personnel for an effective root-cause analysis and proper definition of suitable corrective/preventive actions. /liliInteracts and work with internal department at site for management of change and deviation investigations /liliInteracts with the bCMO /b regarding manufacturing, change, deviations and release activities of the Drug Product. /liliWrites and reviews SOPs, technical reports and other GMP bdocuments /b in compliance with the applicable standards. /liliPerforms a complete breview of the batch production records /b verifying its accuracy, completeness, and presence of relevant attachments in compliance with what prescribed by the relevant SOPs. /liliBefore the manufacturing of a new batch, bissues /b the related batch record and packaging batch record according to what prescribed by relevant SOP. /liliGuaranteesb traceability /b and proper management of the relevant document of the quality system with specific reference to: Batch Records, CoAs, Training Records, Failure/change control records, and other relevant GMP documents. /liliEvaluates bchanges /b for his / her area of competence and performs relevant actions for the change implementation. /liliOrganizes and conduct self-binspections /b to affected departments, supports during audit/inspection from clients/Regulatory Authorities. /liliPerforms bperiodic review /b in production (QAIP) according to relevant SOP. /liliWrites the bProduct Quality Review /b documents. /liliEmbrace the Continuous Improvements mindset by leveraging the Operational Excellence Culture and Tools in the day-to-day activities. /liliFollow Environmental, Health and Safety procedures in compliance with the principle of the company Policy; apply the relevant guidance and indications of the Integrated Management System. /liliAttend education and training courses in the Integrated Management System, GMP, Quality, Procedures, Instructions, manuals, and Operational Protocols. /liliOversee the work and ensure the implementation of directives received, checking the correct performance of workers, and exerting a functional power of initiative as provided by legislative Decree nr. 81/08. /liliEnsure compliance with all applicable Laws, Codes, corporate standards, and Procedures related to her/his area of relevance/responsibility, included the legislative decree 231/2001 and requirements of the Jazz Pharmaceuticals Code of Conduct. /liliStrictly observance and knowledge of Jazz Pharmacovigilance’s Policy. /li /ulpbRequired Knowledge, Skills, and Abilities /b /pulliQuality Management System (Documentation, Training, Suppliers Qualification, Complaints, Deviations, CAPAs, Change Control, Audits. /liliUnderstand and apply regulatory/guidance documents to ensure compliance. /liliTechnical writing skills including protocols, reports, SOPs. /liliAbility to work independently and as part of a team. /li /ulpbRequired/Preferred Education and Licenses /b /pulliRequired: Bachelor's or higher degree level in a life sciences subject. /liliRequired: Experience working in a quality assurance role at a pharmaceutical manufacturing site. /liliRequired: bFluent /bbbI /btalian and English language skills /b /liliPreferred: authorization to operate as a QP according to European Directive2001/83/EC and Italian "Decreto Legislativo n.219 April 2006, as amended, implementing EU Directive 2001/83/EC and Eudralex Vol. 4, Annex 16, as amended. /li /ul /p pemJazz 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. /em /p 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: .