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Quality Assurance Specialist
3 settimane fa
OverviewJazz 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 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.If you are a current Jazz employee please apply via the Internal Career site.Brief DescriptionActive contribution to maintenance and improvement of the Quality System at the Manufacturing site and overview of the CMO activities for Drug Product.Essential Functions / ResponsibilitiesConducts properinvestigationsin case of deviations and appoints the required personnel for an effective root-cause analysis and proper definition of suitable corrective/preventive actions.Defines and verifiesCorrective / Preventive Actionsfollowing investigations.Verifies theapplicationof the Company Quality System (eg. SOPs application, Quality Agreements) by both GMP related relevant departments and external personnel.Makes sure thatcomplaintsfrom 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.Interacts and works with internal department at site for management of change and deviation investigations.Interacts with theCMOregarding manufacturing, change, deviations and release activities of the Drug Product.Writes and reviews SOPs, technical reports and other GMPdocumentsin compliance with the applicable standards.Performs a completereview of the batch production recordsverifying its accuracy, completeness, and presence of relevant attachments in compliance with what prescribed by the relevant SOPs.Before the manufacturing of a new batch,issuesthe related batch record and packaging batch record according to what prescribed by relevant SOP.Guaranteestraceabilityand 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.Evaluateschangesfor his / her area of competence and performs relevant actions for the change implementation.Organizes and conducts self-inspectionsto affected departments, supports during audit/inspection from clients/Regulatory Authorities.Performsperiodic reviewin production (QAIP) according to relevant SOP.Writes theProduct Quality Reviewdocuments.Embrace the Continuous Improvements mindset by leveraging the Operational Excellence Culture and Tools in the day-to-day activities.Follow 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.Attend education and training courses in the Integrated Management System, GMP, Quality, Procedures, Instructions, manuals, and Operational Protocols.Oversee 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. *****.Ensure compliance with all applicable Laws, Codes, corporate standards, and Procedures related to her/his area of relevance/responsibility, including the legislative decree ******** and requirements of the Jazz Pharmaceuticals Code of Conduct.Strictly observance and knowledge of Jazz Pharmacovigilance's Policy.Required Knowledge, Skills, and AbilitiesQuality Management System (Documentation, Training, Suppliers Qualification, Complaints, Deviations, CAPAs, Change Control, Audits).Understand and apply regulatory/guidance documents to ensure compliance.Technical writing skills including protocols, reports, SOPs.Ability to work independently and as part of a team.Required / Preferred Education and LicensesRequired: Bachelor's or higher degree level in a life sciences subject.Required: Experience working in a quality assurance role at a pharmaceutical manufacturing site.Required: Fluent Italian and English language skills.Preferred: Authorization to operate as a QP according to European Directive *******/EC and Italian "Decreto Legislativo n.219April ****, as amended, implementing EU Directive *******/EC and Eudralex Vol.4, Annex 16, as amended.Equal Employment OpportunityJazz 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.BenefitsThe 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.Job TitlesQuality Specialist - TrainingQuality and Training Technician#J-*****-Ljbffr
