Quality Assurance Specialist

Quality Assurance Specialist Jazz 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.If you are a current Jazz employee please apply via the Internal Career site.Brief Description:Active contribution to maintenance and improvement of the Quality System at the Manufacturing site and overview of the CMO activities for Drug Product.Essential Functions / Responsibilities:Conduct investigations in case of deviations and appoint required personnel for effective root-cause analysis and definition of suitable corrective/preventive actions.Define and verify Corrective / Preventive Actions following investigations.Verify the application of the Company Quality System (e.g., SOPs application, Quality Agreements) by both GMP-related relevant departments and external personnel.Ensure complaints from customers and to suppliers are recorded and managed according to Company SOPs and appoint required personnel for root-cause analysis and definition of suitable corrective/preventive actions.Interact and work with internal departments at the site for management of change and deviation investigations.Interact with the CMO regarding manufacturing, change, deviations and release activities of the Drug Product.Write and review SOPs, technical reports and other GMP documents in compliance with applicable standards.Perform a complete review of the batch production records, verifying accuracy, completeness and presence of relevant attachments as prescribed by the relevant SOPs.Before manufacturing a new batch, issue the related batch record and packaging batch record as prescribed by relevant SOP.Guarantee traceability and proper management of the relevant quality system documents: batch records, CoAs, training records, failure/change control records and other relevant GMP documents.Evaluate changes for his/her area of competence and perform relevant actions for change implementation.Organize and conduct self-inspections to affected departments, support during audit/inspection from clients/regulatory authorities.Perform periodic review in production (QAIP) according to relevant SOP.Write the Product Quality Review documents.Embrace the continuous improvement mindset by leveraging the operational excellence culture and tools in day-to-day activities.Follow Environmental, Health and Safety procedures in compliance with the company policy; apply 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 work and ensure implementation of directives received, checking correct performance of workers and exercising functional initiative as provided by Legislative Decree nr. *****.Ensure compliance with all applicable laws, codes, corporate standards and procedures related to area of relevance/responsibility, including Legislative Decree ******** and requirements of the Jazz Pharmaceuticals Code of Conduct.Strictly observe and know Jazz Pharmacovigilance's Policy.Required Knowledge, Skills and Abilities:Quality Management System (documentation, training, supplier 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 Licenses:Required: 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 in Italian and English language skills.Preferred: Authorization to operate as a QP according to European Directive *******/EC and Italian "Decreto Legislativo n. 219 April ****" as amended, implementing EU Directive *******/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.#J-*****-Ljbffr