Quality & Compliance System Senior Specialist
Chiesi
Overview
In this role you will lead and optimize the Quality Management System to ensure GMP, FDA and EU compliance across the site. You will partner with cross-functional teams to drive quality improvements, manage inspections, training, and documentation, and report on QMS performance. You will enable a culture of quality and continuous improvement, shaping robust processes for materials, manufacturing, and release specifications. This is a chance to contribute to a globally recognized biopharmaceutical group focused on sustainable health outcomes.
Retribuzione / Benefits
- comprehensive healthcare programs
- work-life balance initiatives
- relocation support
- competitive salary
- flexible working arrangements
- remote work options
Responsabilità
- Develop and implement QMS processes, procedures, and documentation to meet quality standards
- Monitor and analyze quality data, identify trends, and drive improvement actions
- Prepare periodic QMS performance reports for management
- Collaborate with production, engineering, procurement and other functions to resolve quality issues
- Investigate quality problems, identify root causes, and implement corrective and preventive actions (CAPA)
- Govern and promote a culture of quality and continuous improvement across the site
- Share best practices and ensure activities comply with company procedures
Requisiti fondamentali
- Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering)
- At least 5 years of pharmaceutical/biopharmaceutical experience in QA, Production, and Process Technology
- Excellent knowledge of EU and FDA pharmaceutical guidelines
- Specialized expertise in GMP compliance improvement processes
- Fluent English (written and spoken)
- Strong teamwork and cross-functional collaboration
- Analytical thinking with ability to assess technical issues and propose shared solutions
- Effective communication and stakeholder management
- QMS development and governance
- Quality data analysis and trend identification
- Root cause analysis and CAPA implementation
Offerta di lavoro pubblicata 2 giorni fa
Offerte di lavoro simili
2.000 - 2.800 €/mese
Orienta Spa Agenzia per il Lavoro - filiale di Aversa - ricerca , per azienda operante nel settore delle lavorazioni meccaniche e carpenteria metallica per il comparto ferroviario , un/a RESPONSABILE SISTEMA DI GESTIONE QUALITÀ La risorsa sarà responsabile...ConsigliatoTempo pienoImpiego permanenteTempo determinatoDal lunedì al venerdìOrienta Filiale di Aversa
Marano di Napoli (NA)26 giorni fa35.000 € - 45.000 €
...Ruolo Senior Quality Engineer - RAILWAY Luogo Torino, Genova, Bologna, Firenze, Roma, Napoli e Bari. Di cosa ti occuperai... ...gestione stakeholder. Requisiti Laurea Triennale e/o Specialistica in Ing. Civile, Gestionale e/o affini; Almeno 4 anni di esperienza...SeniorStage/Tirocinio40.000 € - 50.000 €
...recruiting for a Building Structural Senior Engineer to join its office in Naples... ...ensure technical excellence, regulatory compliance, and high-quality project execution while collaborating... ...with RINA's Quality Management System (QMS), applicable regulations and client...Senior- Per ampliamento del nostro team in un punto vendita specializzato nel settore retail a Giugliano in Campania, ricerchiamo un/una Responsabile commerciale che si occupi del coordinamento delle attività di vendita e della gestione dei flussi di clientela. La figura sarà ...SeniorTempo pienoDisponibilità immediataTurniWeekend
Impiegando.com
Giugliano in Campania2 giorni fa - ...implementation of the Physical Security System (CCTV, Access Control System,... ...in terms of time, quality and cost imposed by the different... ...job safety analysis, quality compliance. Adapt to different... ...related to the Physical Security systems Perform commissioning and...SeniorTempo pienoRemoto
- pHitachi Rail STS S.P.A. in Naples, Italy, is seeking a specialist to design and implement Physical Security Systems (CCTV, Access Control, IDS) for tenders and projects, ensuring time, quality, and cost targets are met. /ppYou will analyze customer requirements, create...Senior
- ...Overview In this role you support enterprise customers as a senior technical resource, partnering with development engineers to manage escalations and track bugs. You will create troubleshooting sessions, trainings, and internal knowledge articles, and contribute to...Senior
- pEnduroSat, a fast-growing space scale-up, is seeking a Senior Systems Engineer to support the design and building of our latest generation of satellites. You will coordinate the work of software and hardware engineers by defining and decomposing requirements, communicating...Senior
30.000 € - 36.000 €
Orienta Spa Agenzia per il Lavoro - filiale di Aversa - ricerca , per azienda operante nel settore delle lavorazioni meccaniche e carpenteria metallica per il comparto ferroviario , un/a RESPONSABILE SISTEMA DI GESTIONE QUALITÀ La risorsa sarà responsabile...TemporaneoTempo pienoImpiego permanenteTempo determinatoDal lunedì al venerdì- ...Nexia Audirevi cerca un Senior Auditor per la sede di Napoli. Il candidato coordinerà interventi di revisione contabile per diversi settori e interfaccerà i clienti per fornire supporto tecnico e consulenza. Si richiede almeno 3 anni di esperienza, laurea in economia...Senior
- ...version of ourselves /p /li /ul h3What is the role? /h3 pAs a Senior Systems Engineer you will be able to support the design and building of... ...with high-level requirements decomposition into well-defined system and subsystem requirements /li liAbility to communicate through...SeniorOrario flessibile
- ...collaborate effectively with quality, project management, and product... ..., quality, and process compliance, preparing documentation, and... ...concept activities for embedded systems. /li liDrive software security... ..., product management, system engineering, and other stakeholders...SeniorTurni
- ...with the best version of ourselves What is the role? As a Senior Systems Engineer you will be able to support the design and building... ...with high-level requirements decomposition into well-defined system and subsystem requirements Ability to communicate through and...SeniorOrario flessibile
- ...Senior Expert in Embedded Software Security and Security... ...effectively with quality, project management, and... ...quality, and process compliance, preparing... ...activities for embedded systems. Drive software security... ..., product management, system engineering, and other...SeniorTurni
- ...Software Quality Assurance Specialist (Quality Champion) What You Will Do Act as the quality reference... ...KPIs, etc.) Contribute to process compliance with internal procedures and... ...Engineer, Embedded Developer, Tester, System Engineer) and a good understanding of...
- ...STMicroelectronics Italia is seeking a Software Quality Assurance Specialist (Quality Champion) to support software product teams by acting as... ...will help define quality milestones, contribute to process compliance, and promote best practices in software development....
55.000 € - 65.000 €
Parte del Gruppo MoOngy, Agap2 è presente sul mercato europeo in 14 paesi con servizi di consulenza ingegneristica impiantistica. Dal 2018, Agap2 Italia opera sul territorio nazionale nei seguenti settori: Energy, Oil&Gas, Steel, Hydrogen, Power Generation, Construction...SeniorLavoro ibridoRemoto- ppHome » bSenior AI Engineer (Agentic Systems) /b /ph3Who we are /h3pFrom feasibility study and analysis of the market and trends, to... ...responsibility /ppStrong analytical and problem-solving skills /ppFocus on quality and robustness of solutions /ppTeam-oriented mindset / ability...SeniorStage/TirocinioRemoto
- ...this role you design and implement Physical Security Systems for rail projects, ensuring time, quality, and cost targets across tenders and projects. You... ...including reports, issue tracking, and safety/quality compliance Adapt to diverse cultures and environments to...Senior
- ...learning support, and wellbeing programs. /ppThe role reports to the Dean and Chief Academic Officer, collaborating with faculty and staff to advance student success, professional formation, and regulatory compliance while stewarding budget and resources. /p #J-18808-LjbffrSenior
- pSentinelOne in Napoli, Italy seeks a Senior Threat Intelligence Researcher to lead deep-dive investigations into emerging and known threats. The role focuses on synthesizing complex data into actionable intelligence and maintaining vigilance over malware developments...Senior
- pRINA is recruiting a Building Structural Senior Engineer to join its Naples office in Italy. The role focuses on designing and delivering complex building projects with high autonomy, ensuring compliance with codes and strong project execution while mentoring junior engineers...Senior
- ...and document loans thoroughly. You will interview applicants, assess creditworthiness, and prepare loan packages while ensuring compliance with laws and bank policy. /ppResponsibilities include approving loans, monitoring portfolios, and developing new business relationships...Senior
- ...TFS HealthScience is seeking a Senior Director of Business Development for DIID to lead strategy and client retention across allocated accounts. The role requires coordinating the BD team, driving sales goals, and expanding opportunities across dermatology, immunology...SeniorRemotoLavoro da casa
- pAGAP2 cerca una figura senior di Hardware Design per il settore Aerospace a Napoli. Progetterà e svilupperà sistemi elettronici destinati ad applicazioni aeronautiche, seguendo DO-254 DAL B e collaborando con team multidisciplinari per definizione requisiti e certificazione...Senior
- pGruppo Mondo Media cerca Senior Account B2B per guidare lo sviluppo commerciale dei propri servizi digitali. La figura gestirà lead qualificati, contatti con imprenditori e decision maker, e accompagnerà i clienti dalla proposta alla chiusura. /ppAvrai modo di costruire...Senior
- pAgap2 Italia cerca un Capo Commessa Senior per gestire commesse complesse nel Luxury Hospitality, dall’analisi di gara fino alla gestione operativa di cantiere, coordinando fornitori e team multidisciplinari. Disponibilità a presidio continuo a Capri e forte orientamento...Senior
- pTinexta Innovation Hub ricerca una figura Senior Energy Advisor per sviluppare le strategie di risparmio energetico presso i clienti, ottimizzando consumi e costi e migliorando la sostenibilità economica e ambientale. /ppLa posizione prevede gestione di progetti di efficientamento...Senior
- ...Hitachi Rail STS S.p.A. in Naples, IT, seeks a Senior Supply Chain Planner to handle a broad range of tasks from administration to strategic planning. The role is based in Naples and involves coordinating planning, logistics, and supplier activities within complex projects...Senior
- pDarwin Space is seeking a Senior Hybrid Rocket Propulsion Engineer in Italy. You will develop and optimise hybrid propulsion systems, model combustion chambers, and apply rigorous analysis to real propulsion hardware. /ppThe role requires several years in industry with...SeniorLavoro ibrido
