CSV - Computer System Validation Specialist
Farmabios, an Axplora company
Farmabios SpA, Società appartenente al Gruppo Axplora, un’importante Partner di produzione API e soluzioni CDMO per le più importanti Aziende farmaceutiche e Biotecnologiche, è alla ricerca di una risorsa da inserire nel TEAM Quality Assurance, con esperienza in CSV – Computer System Validation.
Responsabilità
- verificare che la gestione dei sistemi computerizzati aziendali, utilizzati per scopi GMP, sia in compliance ai requisiti di norma e alle correnti linee guida e quindi che soddisfi le aspettative delle principali agenzie regolatorie (FDA e AIFA) e dei nostri clienti
- eseguire la Periodic Review di tutti i sistemi computerizzati aziendali utilizzati per scopi GMP con la frequenza definita in procedura
- eseguire le verifiche periodiche di audit trail di tutti i sistemi computerizzati aziendali utilizzati per scopi GMP
- supportare il reparto IT nel redigere e verificare la corretta applicazione delle procedure aziendali che trattano temi di natura informatica di rilevanza GMP
- verificare la corretta applicazione degli aspetti di data Integrity nei sistemi elettronici
- sarà il referente QA per tutte le attività inerenti la Computer System Validation
- sarà il referente QA per progetti di implementazione di nuovi sistemi informatici utilizzati per scopi GMP (LIMS, SAP e in futuro ad esempio il gestionale documentale, ecc)
Qualifiche
· Laurea in discipline tecnico-scientifiche
· Conoscenza della lingua inglese parlata e scritta
· Conoscenza della normativa di riferimento
· Conoscenza dell’intero ciclo di vita dei software: VP, URS, FS, DS, IQ, OQ, PQ, VR, gestione change
· Conoscenza dei metodi di test e convalida
· Capacità di redazione e revisione della documentazione tecnica informatica e/o di convalida dei sistemi computerizzati
· Esperienza di almeno 3 anni in ruoli analoghi in società del settore chimico farmaceutico o di consulenza
· Esperienza pregressa di gestione diretta di implementazione di un sistema informatico complesso (tipo SAP) in un’azienda chimico-farmaceutica
· Buone doti relazionali, positività e proattività
Offerta
Contratto di lavoro: Tempo Indeterminato – Full Time
Luogo di Lavoro: Gropello Cairoli (PV)
FARMABIOS S.p.A. opera nel rispetto della parità di genere e con l’impegno di sostenere l’inclusività e la diversity.
La ricerca è rivolta ai candidati di entrambi i sessi, in rispetto del principio delle pari opportunità (D.lgs. 198⁄2006).
La preghiamo di sottoporre la sua candidatura evitando di fornire informazioni relative a matrimonio e gravidanza e responsabilità familiari.
Offerta di lavoro pubblicata un mese fa
Offerte di lavoro simili
- ...Overview As a Computer Systems Validation (CSV) Engineer at CAI, you design and execute validation protocols for GMP environments, ensuring compliant, data-grade systems. You will craft and review GxP and 21 CFR Part 11 documentation and guide resolution plans with...Computer
- ...up Apply functional and formal verification methodologies to validate digital designs Collaborate with engineers across multiple... ...SoC verification experience or a PhD in Electrical Engineering, Computer Science, or related field ~ Expertise in advanced verification...Computer
- ...bring-up Apply functional and formal verification techniques to validate digital designs and improve reliability Collaborate with... ...Experience in ASIC/SoC verification or a PhD in Electrical Engineering, Computer Science, or related field with focus on verification...Computer
- ...role, you will shape the next generation IMUs by defining system requirements and guiding MEMS, ASIC, packaging, and... ...concepts and performance Contribute to verification and validation approaches for sensor systems Coordinate interdisciplinary areas to align...Consigliato
35.000 € - 45.000 €
...Overview As IT Application Specialist, you will own the management and evolution of digital/e-commerce applications, with a focus on... ...standards and ways of working Requisiti fondamentali ~ Degree in Computer Science, Information Technology, Engineering or a similar...Computer- ...Pavia, siamo alla ricerca di una risorsa interessata al ruolo di un TechnicalWriter Specialist in ambito Farmaceutico che dovrà garantire la corretta scrittura di protocolli di validazione per le attività di intervento del dipartimento in ambito HW/SW. /pulliAssicurare...
- ...supplier risks Requisiti fondamentali ~4+ years of SaaS security, audits, and compliance experience ~ Bachelor's degree in Computer Science or related field ~ Solid knowledge of cloud environments (AWS, Azure, GCloud) and data privacy laws (GDPR, CCPA, PIPEDA)...Computer
- ...corporate policies and standards Requisiti fondamentali ~3+ years of experience in a similar role ~ Bachelor's degree or higher in Computer Science Engineering, Information Technology, ICT Engineering, or related fields ~ Knowledge of ITIL processes ~ Fluent in...ComputerLavoro ibridoOrario flessibile
- ...commercial documentation as requested by Global CS Commercial Director Requisiti fondamentali Bachelor's or Master's degree in a computer-related field Proven track record in consultative selling of high-technology or cybersecurity solutions, ideally international...ComputerOrario flessibile
- ...Risk Management, IT Compliance, Information Security, Audit, or related areas. ~ Bachelor's or Master's degree in Information Systems, Computer Science, or Business Administration. ~ Experience in risk assessments, control evaluations, audit support, and remediation...ComputerOrario flessibile
- ...Overview As Senior Satellite Verification & Validation Manager, you lead V&V activities across... ...with schedule and budget. You work with system engineers to shape verification... ...and internal teams to deliver validated systems. This role offers impact by shaping how...Stage/Tirocinio
21.250 € - 28.750 €
...AI application. As a member of the ODSP validation team, you will have the opportunity to work... ...device drivers and scripts to full validate leading edge products. You will be involved... .... We use both Windows and Unix systems, Cadence for design, Python, C, and PowerPoint...Impiego permanenteStage/TirocinioTurno di notte- pams OSRAM's LSP - Light Sensors Photonics unit seeks a Validation Engineer to support laboratory testability and develop validation concepts for semiconductor products. You will drive measurement activities, report results, and collaborate with design teams throughout...
- ...traditional sensing—combining light, silicon, and system expertise to enable digital photonics... ...from components to integrated photonics systems —driving performance, scalability, and... ...in the laboratory /liliDevelop validation concepts and methodologies starting from...Turni
- ...traditional sensing—combining light, silicon, and system expertise to enable digital photonics... ...from components to integrated photonics systems —driving performance, scalability, and... ...-growth segments. Lead bring-up and validation of RF, HF, analog, mixed-signal, and...Turni
- ...ams OSRAM's LSP unit seeks a senior validation engineer to lead RF, HF, analog, mixed-signal, and high-speed digital IC validation. You will develop validation plans, characterize performance across process, voltage, and temperature, and drive root-cause analysis for...
- ...Oversee management and optimisation of IT infrastructure and systems Ensure the security and integrity of all IT systems and data... ...and Italian Educational background in Information Technology, Computer Science, or a related field leadership problem-solving...Computer
- ...vendor-related issues progress and highlights Requisiti fondamentali Mobile Network Knowledge/Experience University degree in computer science, telecommunications or equivalent Experience in Mobile Network Operator/Supplier in telecommunications or relevant ICT...Computer
- ...Excellent written and verbal communication with diverse stakeholders Attention to detail, analytical skills, and proficiency with computer-based tools Ability to work independently, navigate ambiguity, adapt to change, and make timely decisions Proven ability to...Computer
- ...client expectations. This position offers influence over study validation, data integrity, and operational procedures within a data-... ...~ English fluency (spoken) and advanced English ~ Advanced computer applications (Microsoft Excel, Word, Inbox) ~ Advanced understanding...Computer
- ...on challenges Align with company focus on AI, Big Data, and digital services Requisiti fondamentali Bachelor's degree in Computer Engineering (minimum) Master's degree in Computer Science or related field is a plus Teamwork mindset Curiosity and drive...Computer
- ...liliSystemVerilog and UVM /liliBroadband optical communication IC verification, including mixed-signal interfaces, high-speed datapaths and system-level use cases /liliAutomated regression environments /liliAdvanced CMOS node experience, including FinFET and/or FD-SOI, is...
- ...progetti di integrazione Salesforce con sistemi terzi Buona conoscenza della lingua inglese (scritta e parlata) Background in Computer Engineering o Computer Science Communication Empathy Intellectual Curiosity Salesforce Omnistudio Salesforce Public...Computer
- ...ability to meet deadlines Excellent problem-solving and analytical skills Ability to adapt quickly to change High level of computer literacy Ability to work cooperatively with colleagues at all levels communication influencing stakeholders...Computer
35.000 € - 45.000 €
...settore Banking, Data & AI Requisiti fondamentali Laurea magistrale o triennale in Economics/Engineering/Statistics/Mathematics/Computer Science o discipline STEM/quantitative Forte interesse per il settore finanziario e tecnologie digitali Orientamento al...ComputerLavoro ibrido- ...product management, digital platforms or AI-enabled products in industrial automation or robotics ~ Master's degree in Engineering, Computer Science, Business Administration or related field ~ Deep understanding of AI, Physical AI, Data Analytics and digital service...Computer
- ...Requisiti fondamentali Bachelor in Finance Master in Finance/Accounting/Business Administration or MBA (optional) Strong computer proficiency with Microsoft Word and Excel Strong analytical, critical thinking and problem-solving skills Ability to learn new...Computer
- ...code to improve our cloud app's user experience and reliability, working in an international environment. /ppRequired: a degree in Computer Science or engineering, 2+ years of development experience, and proficiency in Swift or Objective-C with OO design. Familiarity...ComputerLavoro ibridoOrario flessibile
- ...party integrations Perform root cause analysis and risk assessment/management Requisiti fondamentali ~ University degree in Computer Science or Engineering or related ~5+ years experience in optimizing Web and mobile technologies ~ Agile processes experience...ComputerPermesso di lavoro
- ...interaction across regions and functions Requisiti fondamentali Bachelor's degree in Information Technology, Information Systems, Computer Science, Engineering, Business Administration or related field, or equivalent experience Minimum 7 years in Software Asset...Computer