Caricamento descrizione…

Validation Specialist in Italia, Italia - Jobeax

Validation Specialist in Italia, Italia is listed on Jobeax. Browse 90,000+ vacancies available.

Specific activities and responsibilities:

Plan, coordinate, and execute Computerized System and SW applications Validation (CSV) activities for client projects in compliance with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11 requirements.
Prepare, review, and manage validation documentation, including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, and Validation Reports.
Support clients in ensuring Data Integrity compliance in accordance with ALCOA+ principles and applicable regulatory requirements.
Perform risk assessments to define validation strategies and support regulatory compliance.
Support Change Control, Deviations, CAPAs, periodic reviews, and validation lifecycle activities for computerized systems.
Collaborate with cross-functional client teams (QA, IT, Engineering, Manufacturing, QC, and Validation) to deliver validation projects.
Assess the impact of software implementations, upgrades, and changes on validated systems.
Draft and update SOPs, Validation Master Plans (VMPs), and other GMP documentation for client projects.
Provide validation and compliance support during internal audits, supplier audits, and regulatory inspections.
Contribute to multiple client projects, ensuring delivery within agreed timelines, quality standards, and regulatory expectations.

Required education:

Bachelor's or Master's degree in Engineering, Computer Science, Information Technology, Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related field

Required experience :

4-5 years of experience

Required languages:

Italian and English

Required technical skills:

Knowledge of GxP regulations and GMP requirements applicable to computerized systems.
Good understanding of GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.
Experience with Computerized System Validation (CSV) lifecycle and validation methodologies.
Understanding of software development lifecycle (SDLC) and computerized systems lifecycle management.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

Additional experience and/or skills:

Attention to detail
Team working and proactivity
Problem solving
good Interpersonal skills
customer management
team management
availability to travel is mandatory

Compensation range: €35000 - €45000

The compensation range indicated in this job posting represents an estimated range for the position. The final remuneration will be determined based on the selected candidate’s experience, skills, qualifications, and internal compensation policies, in accordance with applicable EU and local pay transparency and pay equity requirements.

Candidati all'offerta

Offerte simili

Altre offerte simili

Iveco Group

Validation & Verification engineer - Fleet Data Analytics & Validation

1 giorno fa

39.000 € - 45.000 €

... transforming fleet operational data into actionable engineering insights through the definition of monitoring strategies, data analytics methodologies, mission-based validation approaches and dashboard solutions supporting validation, reliability and engineering activities. Working closely with System Validation Engineers and cross-functional ...

Italy, Torino

Stema S.r.l.

Hybrid Powertrain Embedded Validation Academy

1 giorno fa

Ibrido

500 €/mese

l. cerca una risorsa per il programma Kineton Next Gen, academy di 3 mesi centrata sui sistemi powertrain ibrido. Validazione del software embedded a banco e in vettura, con training su Matlab/Simulink/Stateflow, test automatizzati e analisi dati.

Italy, Napoli

S&you Italia

Senior Process Validation Leader - Molding Department

Oggi

... dipartimento Molding di azienda del gruppo situata nel cuore del distretto biomedicale di Mirandola (MO), stiamo selezionando una figura di SENIOR PROCESS VALIDATION LEADER – MOLDING DEPARTMENT La risorsa, rispondendo al V&V Manager e coordinando un piccolo team, avrà la responsabilità di gestire le attività di Verifica ...

Italy, Mirandola

Staff Engineer Controller Validation (f/m/div)

1 giorno fa

43.440 € - 59.730 €

... technology, driving groundbreaking projects, and bringing new ideas to life. Are you in?Your RoleKey responsibilities in your new roleSupport the development of validation test benchesExecute Hardware-in-the-Loop (HiL) testing including firmware validationAnalyze and verify embedded controller behavior against test requirementsDocument ...

Italy, Cascina

Staff Engineer Controller Validation (f/m/div)

1 giorno fa

43.440 € - 59.730 €

Job Summary As a Staff Engineer Controller Validation in our Research & Development team, you will shape the future of technology by developing validation test benches, executing hardware-in-the-loop testing, and ensuring embedded controller compliance. Key Responsibilities - Support the development of validation test benches ...

Italy, Pavia

Hire Feed

Human Data Specialist (Remote)

Oggi

Remoto
Tempo pieno

- Role : Human Data Specialist (Remote) - Location : Remote (Work from Anywhere) Role Overview: We are hiring for one of our clients, seeking a Senior Human Data Manager to work on a full-time basis. This role involves overseeing data collection, validation, and annotation processes to ensure high-quality training datasets ...

Italy, Torino

Galileo Global Education

Digital Marketing Specialist

1 giorno fa

Tempo pieno

26.000 € - 28.000 €

NABA is currently seeking motivated individuals for the role of Digital Marketing Specialist. Reporting directly to the Digital Marketing Acquisition & Performance Manager, the specialist will support the execution, optimization, and continuous improvement of NABA's digital acquisition activities across international markets. ...

Italy, Milano

Amplifon

Global Master Data & Product Data Specialist

2 giorni fa

Ibrido
In sede
Tempo pieno
Contratto

9500 - 20k

... feeling and living to thousands of people across the https://jobeax.com/link/gqD3XIRTMfXble2R the roleWe are currently looking for a role of Global Master Data Specialist to join our HQ Global Corporate team in Supply Chain function. The Global Master Data Specialist executes global product master data management activities ...

Italy, Milano

Global Validation Specialist | Machine Launch Expert

23 giorni fa

ATS Automation Tooling Systems Inc cerca un tecnico da inserire nel team di progetto a Ravenna. Il candidato si occuperà di supportare il team durante l'avviamento delle macchine custom e di eseguire test di validazione per garantire il corretto funzionamento del prodotto.

Italy, Ravenna

Validation Specialist

28 giorni fa

IWT, azienda che opera nel settore del Pharma , è alla ricerca di una risorsa da inserire come Validation Specialist . La risorsa sarà lo specialista per la preparazione e l’esecuzione delle principali attività di validazione e convalida dei prodotti Pharma, sia in azienda che presso il cliente. Tra le principali responsabilità, ...

Italy, Varese

Biopharma Careers

Global R&D QA, Senior Validation, Digital & Data Integrity Specialist (Parma, IT)

17 giorni fa

Remoto

52.000 €

... in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China). Who we are looking for The Global R&D QA, Senior Validation, Digital & Data Integrity Specialist ensures the maintenance in a state of control and validation of software systems involved in GXP process. Ensures Project ...

Italy, Parma

Airbus

Aviation Safety and Compliance Specialist - Specialista in Sicurezza e Conformità Aeronautica

2 giorni fa

... sempre al primo https://jobeax.com/link/Yi98p42bqzLDk6HQ vuoi fare la differenza in un settore in continua evoluzione, unisciti a noi!Stiamo cercando uno **Specialista in Sicurezza e Conformità Aeronautica** che si unisca al nostro team per contribuire attivamente alla gestione della sicurezza e alla conformità delle nostre ...

Italy, Trento

A1 Digital

Cloud Solution Architect (f/m/d)

1 giorno fa

... recognize Exoscale as a robust alternative, built in Europe, for Europe. Location: Italy Job Purpose: As a Cloud Solution Architect, you support our Sales Specialist team in advising prospects and customers on Exoscale services. You lead architectural discussions, design tailored cloud solutions, and ensure technical excellence ...

Italy, Palermo

LMDV Hospitality Group

Treasury Specialist

Oggi

€35k EUR - €40k EUR

... vuol dire contribuire ogni giorno a offrire esperienze di alto livello, in un ambiente dinamico e in continua evoluzione. Siamo alla ricerca di un/a Treasury Specialist, per il nostro Head Quarter sito in Milano! Principali responsabilità - Gestione operativa della tesoreria giornaliera; - Predisposizionee gestione dei pagamenti ...

Italy

Adecco

Travel Specialist

Oggi

Tempo pieno
Contratto

37.000 € - 40.000 €

... internazionale, attiva da oltre trent’anni nell’organizzazione di eventi, congressi, business travel e incentive, Adecco Italia SpA è alla ricerca di 2 Travel Specialist. Le due risorse entreranno a far parte del team Travel: una sarà inserita stabilmente con un contratto a tempo indeterminato, mentre per il 2° inserimento ...

Italy, Torino

studio Domanico

Payroll Specialist

1 giorno fa

In sede
Tempo pieno

... competente, si impegna a garantire la conformità normativa e la precisione nelle operazioni amministrative e fiscali. Descrizione del ruolo Cerchiamo un Payroll Specialist da inserire nel nostro team a Roma zona Policlinico/Piazza Bologna. Questa posizione è a tempo pieno e prevede la presenza in sede. Sarai responsabile della ...

Italy, Torino

studio Domanico

Payroll Specialist

1 giorno fa

In sede
Tempo pieno

Italy, Torino

Tailor&Fox

CONSOLIDATION SPECIALIST

1 giorno fa

35.000 € - 42.000 €

Tailor&Fox – your HR Business Partner – per importante Gruppo operante nei settori Travel, Business Travel e Events - per ulteriore sviluppo dell'area Amministrazione, Finanza e Controllo, ci ha incaricati di ricercare il seguente profilo professionale: Principali attività: A supporto del responsabile di funzione, il

Italy, Milano

MAW

Hr Specialist

1 giorno fa

€23k EUR - €25k EUR

... interessarti entrare a far parte del nostro team. MAW S.P.A. agenzia per il lavoro di Schio (VI), per il potenziamento dell’organico interno seleziona un/una HR specialist La nostra proposta : dopo un opportuno periodo di affiancamento ti sarà affidata la gestione in autonomia dell'intero processo di selezione, finalizzato all’evasione ...

Italy, Schio