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 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.Job title: Senior Quality Assurance SpecialistLocation: On site, Villa Guardia, ComoBrief DescriptionActive contribution to maintenance and improvement of the Quality System at the Manufacturing site and overview of the CMO activities for Drug ProductEssential Functions/ResponsibilitiesIndependently conducts proper investigations in case of deviations and appoints the required personnel for an effective root-cause analysis and proper definition of suitable corrective/preventive actions.Defines and verifies Corrective / Preventive Actions following investigations.Check consistency and application of the Company Quality System (eg. SOPs application, Quality Agreements) by both GMP related relevant departments and external personnel.Makes sure that complaints from customers and to suppliers are recorded and managed according to Company’s SOP and identifies and collaborates with required personnel for an effective root-cause analysis and proper definition of suitable corrective/preventive actions.Coordinate internal department at site for management of change and deviation investigationsSupervises the CMO regarding manufacturing, change, deviations and release activities of the Drug Product.Writes and reviews SOPs, technical reports and other GMP documents in compliance with the applicable standards.Performs a complete review of the batch production records verifying its accuracy, completeness, and presence of relevant attachments in compliance with what prescribed by the relevant SOPs.Before the manufacturing of a new batch, issues the related batch record and packaging batch record according to what prescribed by relevant SOP.Guarantees traceability 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.Evaluates changes for his / her area of competence and performs relevant actions for the change implementation.Organizes and conducts self-inspections to affected departments, supports during audit/inspection from clients/Regulatory Authorities.Performs periodic review in production (QAIP) according to relevant SOP.Writes, reviews or approves the Product Quality Review documents.Provide and organize training for both internal and external personnel according to what prescribed by relevant procedures.Collaborates in the supervision of the rules and registrations related to the use of narcotic substances on the site.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. 81/08.Ensure 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.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 in6gft quality assurance at a pharmaceutical manufacturing site.Preferred: 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.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:.
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