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FU
Fusion Consulting
3mo ago

Senior Validation & Test Manager(m/w/x)

Frankfurt am Main
Full-timeWith Home OfficeSenior

Description

As a Senior Validation & Test Manager, you will lead efforts to ensure compliance and quality throughout SAP implementations and digital transformations, focusing on validation strategies and testing activities that meet global regulatory standards.

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Requirements

  • •Bachelor’s or Master’s in Life Sciences, IT, Engineering, or related field
  • •5+ years in validation/testing within GxP-regulated environments
  • •Strong understanding of CSV, GAMP 5, 21 CFR Part 11, Annex 11, ISO 9001/27001
  • •Experience with SAP transformation/enhancement projects
  • •Excellent communication and stakeholder engagement skills
  • •Fluent in English; German is a strong plus

Education

Bachelor's degree

Work Experience

5 years

Tasks

  • •Develop and implement validation and test strategies
  • •Ensure validation deliverables meet good documentation practices
  • •Oversee validation and testing activities across systems
  • •Apply a risk-based approach to validation and testing
  • •Drive CAPA management and deviation investigations
  • •Serve as the central contact for validation and compliance activities

Languages

English – Business Fluent

German – Basic

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