10 annunci per il ruolo di sector consultant | - vimercate, lom (recruiting in corso)

CSA & Quality Compliance Expert
NTT Ltd —Milano, Lombardia
- Medicina
- Ingegneria
- Inglese
- Lavoro da casa
Critical Infrastructure Mechanical Engineer, Field Engineering
Amazon Data Services Italy S.R.L. —Milano, Lombardia
- Tempo pieno
- Inglese
- AWS
- Laurea triennale
Engineering & Construction - Infrastructure sector | Junior Consultant INTERNSHIP - Milano (ADV)
PWC Italy —Milano, Lombardia
- 800 € al mese
- Tempo pieno
Senior Data Analyst, Geospatial
NextEnergy Group —Milano, Lombardia
- AutoCAD
- Microsoft Excel
- Gestionale
Candidatura rapida
6 giorni
Senior Regulatory Specialist (Milan, Italy)
Bo Growth —Milano, Lombardia
- Spagnolo
- Inglese
- Laurea magistrale
1 giorno
Senior Tax Consultant - Family Office & Private Client | Milano 1
KPMG —Milano, Lombardia
- Microsoft Excel
- Inglese
- Microsoft Office
EPM Business Consultant
BearingPoint Italy —Milano, Lombardia
- 33.000 € - 42.000 € all'anno
- Ingegneria
- Inglese
- Laurea magistrale
11 ore
Lead Electrical Systems Engineer
Centelec Norte Energy Systems SRL —Milano, Lombardia
- 64.000 € - 76.000 € all'anno
- Tempo pieno
- AutoCAD
- Inglese
- Ingegneria elettrica
Candidatura rapida
10 ore
Junior Consultant - Sustainability & Climate Change
KPMG —Milano, Lombardia
- Ingegneria
- Inglese
- Laurea magistrale
18 ore
Senior Grid Connection Manager - Partita IVA
Hunter Philips —Milano, Lombardia
- Remoto
- Inglese
- Ingegneria elettrica
14 ore

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CSA & Quality Compliance Expert

NTT Ltd -
Milano, Lombardia

Candidati adesso

Dettagli della posizione

Benefit

Lavoro da casa

Qualifiche

Medicina
Ingegneria
Sistemi di gestione delle informazioni di laboratorio
Inglese

Descrizione completa della posizione

CSA & Quality Compliance Expert with 3-5 years of experience in Computer System Validation to support compliance and validation projects for our clients, including top pharmaceutical, biotech, and medical device companies.

Role Description

The selected candidate will work as a consultant on client projects, managing and supporting the validation of computerized systems in regulated environments. They will contribute to strategic initiatives in Life Science and Medical Device compliance, ensuring systems align with regulatory requirements, GxP/ISO standards, and industry best practices. Knowledge of medical device compliance is considered a plus.

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).

Costruisci il tuo futuro con NTT DATA.

Entra a far parte di un’azienda globale, leader nei servizi di business e tecnologici, che ascolta la tua voce e riconosce il valore del tuo lavoro. Collaborerai con clienti, partner e colleghi di tutto il mondo per creare soluzioni innovative capaci di avere un impatto reale sulla società. Qui potrai sviluppare nuove competenze e ampliare il tuo network.

Siamo presenti in Italia con oltre 6000 dipendenti a Milano, Roma, Torino, Genova, Bologna, Treviso, Pisa, Padova, Napoli, Cosenza, Bari e Salerno.

Make this the place where you grow.

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