CSA & Quality Compliance Expert
3 giorni fa
Perché NTT DATA? Come società Global Top Employer abbiamo costruito un'azienda in cui la cura, l’ascolto delle persone, il loro benessere e sviluppo delle competenze sono la nostra priorità. Crediamo nel talento e nell’evoluzione professionale, supportati da formazione continua, programmi di apprendimento avanzati e piani di crescita personalizzati. Facciamo parte di NTT Group, che investe oltre 3,6 miliardi di dollari ogni anno in ricerca e sviluppo per aiutare organizzazioni e società a muoversi con fiducia e sostenibilità verso il futuro digitale. Siamo presenti in Italia con oltre 6000 dipendenti a Milano, Roma, Torino, Genova, Bologna, Treviso, Pisa, Napoli, Cosenza, Bari e Salerno. CSA & Quality Compliance Expert 3-5 anni di esperienza in Computer System Validation per supportare progetti di conformità e validazione per clienti, inclusi top pharmaceutical, biotech e medical device companies. Role Description Il candidato selezionato lavorerà come consulente su progetti client, gestendo e supportando la validazione di sistemi informativi in ambienti regolamentati. Contributo a iniziative strategiche per Life Science e Medical Device compliance, assicurando l'allineamento con requisiti regolatori, standard GxP/ISO e best practice del settore. La conoscenza della compliance dei dispositivi medici è considerata un vantaggio. Key Responsibilities Draft and review validation documentation in compliance with industry regulations. Participate in validation projects for computerized systems, including ERP, MES, LIMS, SCADA and Data Integrity solutions. Support compliance projects in the Medical Device sector, ensuring adherence to ISO 13485, EU MDR and other relevant regulations. Perform risk assessments and impact analyses for computerized systems in both pharma/biotech and medical device environments. Collaborate with cross-functional teams, including IT, QA and operations, to ensure compliance with standards and regulations. Provide support during client and regulatory audits (FDA, EMA, ISO etc.), supplying evidence and required documentation. Deliver training and guidance to client personnel on validation and compliance activities for Life Science and Medical Device sectors. Requirements Degree in scientific or technical disciplines (Engineering, Computer Science, Biotechnology, Chemistry etc.). At least 3-5 years of experience in CSA activities within Life Science. Solid understanding of regulatory guidelines: GAMP 5, FDA 21 CFR Part 11, EU Annex 11. Experience with risk-based validation approaches and familiarity with software validation in GxP contexts. Ability to manage complex projects and effectively collaborate with clients across multiple industries. Excellent analytical, planning and problem-solving skills. Proficiency in English, both written and spoken. Sede di lavoro Milano, con possibilità di modalità di lavoro Ibrida (Smart Working). Unisciti a noi Third parties fraudulently posing as NTT DATA recruiters. NTT DATA recruiters will never ask job seekers and candidates for payment or banking information during the recruitment process, for any reason. Please remain vigilant of third parties that may try to impersonate NTT DATA recruiters, either in writing or by phone, in an attempt to deceptively obtain personal data or money from you. All email communications from an NTT DATA recruiter will be associated with an @ #J-18808-Ljbffr
-
WorkFromHome, Italia NTT DATA Europe & Latam A tempo pienoUna società globale di servizi IT cerca un CSA & Quality Compliance Expert in Lombardia. Il candidati gestirà progetti di validazione in ambienti regolamentati per clienti nel settore farmaceutico e dei dispositivi medici. È richiesta una laurea in discipline scientifiche e almeno 3-5 anni di esperienza nel settore Life Science. Il lavoro prevede...
-
Field Service Representative
2 settimane fa
WorkFromHome, Italia CSA Group A tempo pienoJob Summary The Field Service Representative maintains the integrity of the CSA registered mark by conducting factory inspections and safeguarding on‑going conformity of products bearing the CSA Mark. Responsibilities Conducting factory inspections at CSA authorized factories (remote and on‑site). Selecting representative product samples to audit;...
-
Senior Director, Quality and Compliance
4 settimane fa
WorkFromHome, Italia European Institute of Policy Research and Human Rights- Policy Research Section (SRFP Department) A tempo pienoTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. Join Our Team as a Senior Director, Quality and Compliance...
-
Senior Director, Quality and Compliance
3 settimane fa
WorkFromHome, Italia Four Corners A tempo pieno2 giorni fa TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. Join Our Team as a Senior Director, Quality and...
-
Quality and Compliance Specialist
3 settimane fa
WorkFromHome, Italia Var Group A tempo pienoUnisciti a noi come Quality & Compliance Specialist! Sede: Empoli/Milano/Bologna Contratto: Tempo indeterminato Chi siamo Var Group , realtà di riferimento nel panorama dell’innovazione digitale in Italia, affianca le imprese nel loro percorso di trasformazione grazie alla professionalità di oltre 4.200 persone distribuite in 15 paesi nel mondo . Dal...
-
Global Quality
4 settimane fa
WorkFromHome, Italia European Institute of Policy Research and Human Rights- Policy Research Section (SRFP Department) A tempo pienoA global mid-size Contract Research Organization is seeking a Senior Director, Quality and Compliance. This role includes ensuring compliance and inspection readiness, leading a skilled team, and overseeing Quality Management Systems. The ideal candidate will have a life science degree and a minimum of 10 years in clinical research and auditing within GxP...
-
Global Director of Quality
3 settimane fa
WorkFromHome, Italia Four Corners A tempo pienoA global research organization is seeking a Senior Director of Quality and Compliance to oversee compliance operations and ensure inspection readiness. This role requires at least 10 years of experience in clinical research and auditing, along with leadership skills to manage a quality team. The position comes with a competitive compensation package and...
-
Compliance expert
1 settimana fa
WorkFromHome, Italia Praxi spa - filiale di Roma Tiburtina - filiale di Roma Tiburtina A tempo pienoLuogo di lavoro Brescia Principali Attività La risorsa, riportando direttamente al General Counsel, avrà il compito di garantire la conformità dell'azienda alle normative nazionali e internazionali, con particolare attenzione alle leggi sul commercio internazionale e alle sanzioni internazionali. Opererà come punto di riferimento per la definizione,...
-
Remote Quality
2 settimane fa
WorkFromHome, Italia Brambles A tempo pienoA leading logistics company is seeking a technical solution provider to implement quality audits and deliver training in Italy. The candidate will support customers by providing proactive solutions to supply chain challenges and conducting compliance audits. Ideal applicants should possess technical knowledge of logistics and packaging, experience in...
-
EXPERT PROCESS MONITORING
3 settimane fa
WorkFromHome, Italia Plenitude A tempo pienoEXPERT PROCESS MONITORING & COMPLIANCE (IT) Come Expert Process Monitoring & Compliance , farai parte di Plenitude Società Benefit . In particolare, entrerai nel team Digital & IT Strategy, Services & Governance , all’interno dell’ambito Process Monitoring & Compliance che si occupa di sviluppo e innovazione dei processi, garantendo la loro conformità...
