Regulatory Affairs And Quality Specialist
4 mesi fa
Le responsabilità si concentreranno su : sottomissioni e monitoraggio delle pratiche regolatorie mediante i principali portali EU; attività regolatorie relative al ciclo di vita dei medicinali (trasferimento titolarità, registrazioni, variazioni e rinnovi delle AIC per procedure Nazionali, di Mutuo Riconoscimento, Decentrate e Centralizzate in conformità ai requisiti normativi EU e locali); allestire documenti amministrativi e redigere/revisionare documentazione tecnica (CTD- e-CTD) per medicinali nuovi e/o già parte del listino; seguire, in accordo con le strategie definite dalla Direzione, l'operatività per la registrazione e il lancio di nuovi prodotti in Italia e/o Estero; interfacciarsi con le Autorità competenti: AIFA, Ministero della Salute; supportare la Direzione nel mantenimento del Sistema di Gestione Qualità e di Farmacovigilanza in conformità alla normativa vigente, assicurando che l'Azienda operi nel rispetto di tutte le normative in materia di legislazione farmaceutica per la registrazione e la distribuzione dei propri prodotti; monitorare la legislazione vigente sui Farmaci, Dispositivi Medici e Nutraceutici; interfacciarsi con le Funzioni QA, Farmacovigilanza e Direzione Medica.
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Regulatory Affairs Specialist
3 settimane fa
Modena, Emilia-Romagna, Italia Capgemini A tempo pienoJoin Our Team as a Regulatory Affairs SpecialistCapgemini Engineering is seeking a highly skilled Regulatory Affairs Specialist to join our team in Rome. As a key member of our team, you will be responsible for supporting the RAQSM and process owners in the development of quality management procedures in accordance with UNI EN ISO 13485 standards. Your...
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Quality And Regulatory Specialist
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Modena, Italia Datalogic A tempo pienoJob Description The Quality and Regulatory Specialist will play a crucial role in ensuring that our products, photoelectric sensors, safety light curtains, ultrasonic sensors, etc. comply with European Directive and International Standards. This position will be responsible for implementing and maintaining quality management systems, conducting audits, and...
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Quality And Regulatory Specialist
1 mese fa
Modena, Italia Datalogic A tempo pienoJob DescriptionThe Quality and Regulatory Specialist will play a crucial role in ensuring that our products, photoelectric sensors, safety light curtains, ultrasonic sensors, etc. comply with European Directive and International Standards.This position will be responsible for implementing and maintaining quality management systems, conducting audits, and...
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Quality and Regulatory Specialist
4 settimane fa
Modena, Italia Datalogic A tempo pienoJob Description The Quality and Regulatory Specialist will play a crucial role in ensuring that our products, photoelectric sensors, safety light curtains, ultrasonic sensors, etc. comply with European Directive and International Standards. This position will be responsible for implementing and maintaining quality management systems, conducting audits,...
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Atmp Cmc Regulatory Affairs Expert
5 mesi fa
Modena, Italia Evotec A tempo pienoThe Modena Site is a young acquisition with state of the art cell factory, certified by AIFA. The team at site consists of appr. 25 FTE with strong background in cell therapy development. The site offers options for significant expansion and highly specialized development for iPSC-derived therapies. To efficiently support ongoing activities and needs in the...
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Senior Quality Control Specialist
1 mese fa
Modena, Emilia-Romagna, Italia Staff S.p.A. Filiale di Bergamo A tempo pienoJob Title: Senior Quality Control SpecialistStaff S.p.A. Filiale di Bergamo is seeking a highly skilled Senior Quality Control Specialist to join our team.Job Summary:We are looking for a senior quality control specialist to manage our quality system, ensuring compliance with regulatory requirements and industry standards. The ideal candidate will have a...
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Regulatory Affairs Specialist
2 settimane fa
Modena, Emilia-Romagna, Italia Capgemini Engineering A tempo pienoLa nostra azienda Capgemini Engineering, leader nel settore dell'ingegneria e delle tecnologie, è alla ricerca di un Regulatory Affairs Specialist per la sua sede di Roma.Descrizione del ruolo: Il candidato ideale sarà un esperto in regolamentazione dei dispositivi medici e prodotti farmaceutici, con esperienza in sistemi di gestione della qualità e norme...
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Senior Quality Control Specialist
1 mese fa
Modena, Emilia-Romagna, Italia Staff S.p.A. Filiale di Bergamo A tempo pienoJob Title: Senior Quality Control SpecialistWe are seeking a highly skilled and experienced Senior Quality Control Specialist to join our team at Staff S.p.A. Filiale di Bergamo. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our products and processes.Key Responsibilities:Develop and...
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Senior Quality Control Specialist
1 mese fa
Modena, Emilia-Romagna, Italia STAFF SPA A tempo pienoJob Title: Senior Quality Control SpecialistWe are seeking a highly skilled Senior Quality Control Specialist to join our team at STAFF SPA. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our products and processes.Key Responsibilities:Develop and implement quality control procedures to...
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Senior Quality Control Specialist
4 settimane fa
Modena, Emilia-Romagna, Italia STAFF SPA A tempo pienoJob DescriptionStaff Spa is seeking a highly skilled Senior Quality Control Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the highest standards of quality in our frozen food products.Key Responsibilities:Develop and implement quality control procedures to ensure compliance with...
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Quality Control Specialist
1 mese fa
Modena, Emilia-Romagna, Italia Randstad Italia spa A tempo pienoJob Title: Quality Control SpecialistAre you an expert in mechanical quality control with experience in the ceramics stamping industry? Do you have a passion for ensuring the highest quality products? Randstad Italia, on behalf of a leading client, is seeking a skilled professional like you to join their team.Job Summary:We are looking for a Quality Control...
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Quality Assurance Specialist
1 mese fa
Modena, Emilia-Romagna, Italia Evotec Modena Srl A tempo pieno**About Evotec Modena Srl**Evotec Modena Srl is a leading biotechnology company specializing in the discovery and development of novel small molecule drugs. With operational sites in Europe and the US, the company has built substantial expertise in drug discovery and development, as well as an industrialized platform for driving new innovative small molecule...
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Quality Specialist
5 mesi fa
Modena, Italia Reflexallen Group A tempo pieno**Group**, multinational company with several plants around the world and headquarters on the hills of Modena, international leader of design, development and production of Automotive components, is looking for a **Quality Specialist.** **Main Activities**: - Draft and review the company’s quality plan - Development of standard process and product...
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Regulatory Affairs Middle
2 mesi fa
Modena, Italia Capgemini A tempo pienoCapgemini Engineering è alla ricerca di Regulatory Affairs Specialist per la sede di Roma.La risorsa sarà coinvolta in progetti afferenti al settore Biomedicale e si occuperà delle seguenti attività:Supportare il RAQ&SM e i responsabili di processo nella redazione delle procedure del Sistema di Gestione Qualità secondo le norme UNI EN ISO...
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Regulatory Affairs Middle
2 mesi fa
Modena, Italia Capgemini A tempo pienoCapgemini Engineering è alla ricerca di Regulatory Affairs Specialist per la sede di Roma.La risorsa sarà coinvolta in progetti afferenti al settore Biomedicale e si occuperà delle seguenti attività:Supportare il RAQSM e i responsabili di processo nella redazione delle procedure del Sistema di Gestione Qualità secondo le norme UNI EN ISO...
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Regulatory Affairs Middle
4 settimane fa
Modena, Italia Capgemini A tempo pienoCapgemini Engineering è alla ricerca di Regulatory Affairs Specialist per la sede di Roma. La risorsa sarà coinvolta in progetti afferenti al settore Biomedicale e si occuperà delle seguenti attività: Supportare il RAQ&SM e i responsabili di processo nella redazione delle procedure del Sistema di Gestione Qualità secondo le norme UNI EN ISO 13485; ...
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Regulatory Affairs Middle
1 mese fa
Modena, Italia Capgemini A tempo pienoCapgemini Engineering è alla ricerca di Regulatory Affairs Specialistper la sede di Roma.La risorsa sarà coinvolta in progetti afferenti al settore Biomedicale e si occuperà delle seguenti attività:Supportare il RAQ&SM e i responsabili di processo nella redazione delle procedure del Sistema di Gestione Qualità secondo le norme UNI EN ISO...
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Regulatory Affairs Middle
2 giorni fa
Modena, Italia Capgemini A tempo pienoCapgemini Engineering è alla ricerca di Regulatory Affairs Specialist per la sede di Roma. La risorsa sarà coinvolta in progetti afferenti al settore Biomedicale e si occuperà delle seguenti attività: Supportare il RAQ&SM e i responsabili di processo nella redazione delle procedure del Sistema di Gestione Qualità secondo le norme UNI EN ISO 13485; ...
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Quality Control Specialist
4 settimane fa
Modena, Emilia-Romagna, Italia Gi Group S.P.A A tempo pienoJoin Gi Group S.P.A. as a Quality Control SpecialistWe are seeking a highly skilled Quality Control Specialist to join our team at Gi Group S.P.A. in Modena, Italy. As a Quality Control Specialist, you will be responsible for ensuring the quality of our products by conducting dimensional inspections, managing scrap, and coordinating production progress.Key...
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Quality Assurance Specialist
3 settimane fa
Modena, Emilia-Romagna, Italia Evotec Modena Srl A tempo pienoJob Title: Quality Assurance SpecialistEvotec Modena Srl is a leading company in the discovery and development of novel small molecule drugs. We are seeking a highly motivated Quality Assurance Specialist to join our Cell and Gene therapy team.Key Responsibilities:Manage a comprehensive documentation system for all Cell Factory operationsCollaborate in risk...