Computer System Validation
2 settimane fa
Computer System Validation (CSV) Specialist – Sede: Milano Sede : Milano, Lombardia(IT) Tipo di Impiego : Full Time Descrizione del ruolo La risorsa sarà inserita nel team Quality/Compliance e si occuperà delle attività di convalida e qualificazione dei sistemi informatici utilizzati in ambito GxP (farmaceutico, medical device o biotech). Supporterà i progetti IT e Quality garantendo la conformità alle normative vigenti (GAMP 5, FDA 21 CFR Part 11, EU Annex 11). Responsabilità principali Sviluppo e aggiornamento della documentazione CSV: URS, RA, Validation Plan, IQ/OQ/PQ, Traceability Matrix, Validation Report. Esecuzione e revisione di test di convalida su sistemi software, strumenti di laboratorio, LIMS, ERP o MES. Gestione del ciclo di vita dei sistemi informatici secondo principi GAMP 5. Collaborazione con team cross-funzionali (IT, QA, Produzione, Laboratorio). Conduzione di valutazioni dei rischi (Risk Assessment) e definizione delle strategie di convalida. Gestione delle deviazioni, change control e CAPA legati ai sistemi informatici. Supporto in audit interni ed esterni (AIFA, FDA, clienti). Monitoraggio della compliance e aggiornamento alle normative di settore. Requisiti Laurea in discipline scientifiche (Ingegneria, Chimica, Biotecnologie, Informatica o affini). Esperienza di almeno 1–3 anni in attività di Computer System Validation, preferibilmente in ambito Life Sciences. Conoscenza approfondita di GAMP 5, 21 CFR Part 11, Annex 11 e linee guida GxP. Buona capacità di redazione documentale in inglese e italiano. Approccio analitico, precisione e buone capacità di problem-solving. Capacità di lavorare in team e di gestire più progetti contemporaneamente. Se pensi possa essere l'opportunità giusta per te, non esitare a candidarti e ad inoltrarci il tuo CV
-
Pega System Architect
3 settimane fa
Milan, Lombardy, Italy, Provincia di Milano Reply A tempo pienoAre you an IT Consultant expert in Pega Solutions ? We are Reply, and we are looking for you! WHO WE ARE Reply is a company that specialises in Consulting , Systems Integration and Digital Services with a focus on the conception, design and implementation of solutions based on the new communication channels and digital media. Reply partners with key...
-
Validation Specialist
3 settimane fa
Piombino Dese, Veneto, Italy, Provincia di Padova Stevanato Group A tempo pienoWe are looking for a Validation Specialist – Quality to join our HQ team in Piombino Dese (Padova) . The chosen candidate will be responsible to execute the qualification and validation processes assigned, maintains UpToDate and improves the quality system tools, guidelines, and other procedures aimed at achieving reliability and compliance, in alignment...
-
Support Engineer
3 settimane fa
Milan, Lombardy, Italy, Provincia di Milano Adecco A tempo pienoAdecco is looking for an Support Engineer II for an international client company. If you have experience in onsite technical support and want to join a global tech organization, this is your opportunity! Responsibilities Handle technical support requests via chat, phone, email, and ticketing system. Diagnose and resolve issues on Windows, Mac, and Linux...
-
Oracle HCM Cloud Architect
2 settimane fa
Milan, Lombardy, Italy, Provincia di Milano Thrive IT Systems A tempo pienoJob Title: Oracle HCM Cloud Architect / Senior HCM Consultant Location: Italy (Full-Time) Experience: 12 Years Employment Type: FTE Job Description We are looking for an experienced Oracle HCM Cloud Architect / Senior HCM Consultant with strong functional and technical expertise across HCM modules. The ideal candidate will lead solution design, architecture,...
-
Systems Administrator
3 settimane fa
Lombardy, Italy, Provincia di Milano E-Frontiers A tempo pienoAt E-Frontiers we're on the lookout for a System Administrator to join a growing global IT company based in several European regions, with heardquarters in Spain. The role involves managing and maintaining datacenter infrastructure, ensuring smooth operation of critical systems, and supporting hardware lifecycle processes. The ideal candidate is a...
-
IT Support Specialist
2 settimane fa
Milan, Lombardy, Italy, Provincia di Milano Microsoft Power BI, Python, JavaScript, C++ , Microsoft Azure, Microsoft 365, Microsoft Word A tempo pienoCompany Description We suggest you enter details here. Role Description This is a full-time, on-site role for an IT Support Specialist located in Milan. The IT Support Specialist will provide technical support to end users, address and resolve system and software issues, and assist with troubleshooting hardware and software problems, including desktop...
-
Senior Project Manager
2 settimane fa
Milan, Lombardy, Italy, Provincia di Milano Inuka Partners A tempo pienoOverview: Inuka is working with a leading renewable energy company to hire a Senior Project Manager – BESS, based in Milan. The role will oversee the full technical delivery of utility-scale battery energy storage projects, ensuring high-quality engineering, smooth execution, and successful commissioning across Italy and broader Europe. Responsibilities:...
-
Mid-Senior Pre-Sales Solution Engineer
3 settimane fa
Milan, Lombardy, Italy, Provincia di Milano Hikrobot A tempo pienoJoin Us to Build the Future of Smart Logistics in Italy! We are a leading Chinese robotics and automation company expanding rapidly across Europe, delivering intelligent logistics and manufacturing solutions powered by AGV and AMR technologies . To support our continued growth, we’re looking for a Solution Engineer based in Italy to join our dynamic...
-
Mid-Senior Pre-Sales Solution Engineer
3 settimane fa
Milan, Lombardy, Italy, Provincia di Milano Hikrobot A tempo pienoJoin Us to Build the Future of Smart Logistics in Italy! We are a leading Chinese robotics and automation company expanding rapidly across Europe, delivering intelligent logistics and manufacturing solutions powered by AGV and AMR technologies . To support our continued growth, we’re looking for a Solution Engineer based in Italy to join our dynamic...
-
PPM Specialist, Italy
2 settimane fa
Milan, Lombardy, Italy, Provincia di Milano ION A tempo pienoAbout us: Cedacri is part of ION Group, a community of visionary innovators dedicated to providing pioneering software and consultancy services to financial institutions, trading firms, central banks, governments, and corporations worldwide. We strive to simplify the way people work by providing workflow and process automation software, real-time data and...