ALTEN
Computer System Validation Expert(m/w/x)
Full-timeWith HomeofficeExperienced
Frankfurt am Main
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AL
ALTENFDA Part 11 / CSV Validation Expert(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
Description
In dieser Rolle sicherst du die FDA-Konformität von IT-Systemen, indem du präzise Audits sowie GAP-Analysen durchführst und die Implementierung rechtssicherer Signaturprozesse begleitest.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Studium in Life Sciences, Informatik, Engineering oder vergleichbar
- •Kenntnisse der FDA-Regularien (21 CFR Part 11, Part 820/QSR) und GMP
- •Erfahrung im Bereich Computer System Validation (CSV)
- •Audit-Erfahrung (intern/extern) in regulierten Branchen
- •Fließende Deutsch- und Englischkenntnisse
Education
Bachelor's degree
Work Experience
approx. 1 - 4 years
Tasks
- •IT-Systeme, Software und Prozesse auf FDA-Konformität prüfen
- •GAP-Analysen zur Datenintegrität durchführen
- •Risikobewertungen zur Datenintegrität erstellen
- •Audit-Ergebnisse dokumentieren
- •CAPA-Pläne erstellen
- •Bei der Implementierung elektronischer Signaturprozesse beraten
Tools & Technologies
FDA-Regularien21 CFR Part 11Part 820/QSRGMPComputer System Validation (CSV)
Languages
German – Business Fluent
English – Business Fluent
Benefits
Career Advancement
- •Talent Management
Flexible Working
- •Flexible Arbeitszeiten
- •Mobiles Arbeiten
Healthcare & Fitness
- •EGYM Wellpass
Company Bike
- •Dienstradleasing
Public Transport Subsidies
- •Vergünstigte Green Mobility
Job Security
- •Unbefristeter Arbeitsvertrag
Corporate Discounts
- •Corporate Benefits
Team Events
- •Teamevents
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ALTEN and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
- SYNTEGON
Validierungs-Spezialist:in CSV(m/w/x)
Full-timeWith HomeofficeExperiencedFrankfurt am Main - SYNTEGON
Senior CSV-Consultant(m/w/x)
Full-timeWith HomeofficeManagementFrankfurt am Main - Deloitte GmbH Wirtschaftsprüfungsgesellschaft
Senior Consultant IT Quality & CSV / Life Sciences(m/w/x)
Full-timeWith HomeofficeSeniorBerlin, Düsseldorf, Frankfurt am Main, Köln, München - Capgemini
IT Validation Consultant(m/w/x)
Full-time/Part-timeWith HomeofficeJuniorBerlin, Hannover, Karlsruhe, Wolfsburg, München, Erfurt, Stuttgart, Köln, Frankfurt am Main, Ingolstadt
AL
ALTENFDA Part 11 / CSV Validation Expert(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeExperienced
New Job?Nejo!
The AI Job Search Engine
Description
In dieser Rolle sicherst du die FDA-Konformität von IT-Systemen, indem du präzise Audits sowie GAP-Analysen durchführst und die Implementierung rechtssicherer Signaturprozesse begleitest.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Studium in Life Sciences, Informatik, Engineering oder vergleichbar
- •Kenntnisse der FDA-Regularien (21 CFR Part 11, Part 820/QSR) und GMP
- •Erfahrung im Bereich Computer System Validation (CSV)
- •Audit-Erfahrung (intern/extern) in regulierten Branchen
- •Fließende Deutsch- und Englischkenntnisse
Education
Bachelor's degree
Work Experience
approx. 1 - 4 years
Tasks
- •IT-Systeme, Software und Prozesse auf FDA-Konformität prüfen
- •GAP-Analysen zur Datenintegrität durchführen
- •Risikobewertungen zur Datenintegrität erstellen
- •Audit-Ergebnisse dokumentieren
- •CAPA-Pläne erstellen
- •Bei der Implementierung elektronischer Signaturprozesse beraten
Tools & Technologies
FDA-Regularien21 CFR Part 11Part 820/QSRGMPComputer System Validation (CSV)
Languages
German – Business Fluent
English – Business Fluent
Benefits
Career Advancement
- •Talent Management
Flexible Working
- •Flexible Arbeitszeiten
- •Mobiles Arbeiten
Healthcare & Fitness
- •EGYM Wellpass
Company Bike
- •Dienstradleasing
Public Transport Subsidies
- •Vergünstigte Green Mobility
Job Security
- •Unbefristeter Arbeitsvertrag
Corporate Discounts
- •Corporate Benefits
Team Events
- •Teamevents
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ALTEN and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
ALTEN
Industry
Engineering
Description
The company is one of the world’s leading engineering service providers, committed to shaping the future through innovative solutions.
Not a perfect match?
- ALTEN
Computer System Validation Expert(m/w/x)
Full-timeWith HomeofficeExperiencedFrankfurt am Main - SYNTEGON
Validierungs-Spezialist:in CSV(m/w/x)
Full-timeWith HomeofficeExperiencedFrankfurt am Main - SYNTEGON
Senior CSV-Consultant(m/w/x)
Full-timeWith HomeofficeManagementFrankfurt am Main - Deloitte GmbH Wirtschaftsprüfungsgesellschaft
Senior Consultant IT Quality & CSV / Life Sciences(m/w/x)
Full-timeWith HomeofficeSeniorBerlin, Düsseldorf, Frankfurt am Main, Köln, München - Capgemini
IT Validation Consultant(m/w/x)
Full-time/Part-timeWith HomeofficeJuniorBerlin, Hannover, Karlsruhe, Wolfsburg, München, Erfurt, Stuttgart, Köln, Frankfurt am Main, Ingolstadt