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Computer System Validation Expert (m/f/x)

  • Location: Sachsen
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 29 days ago

  • Sector: Biotech
  • Contact: Clodagh Quigg
  • Contact Email: c.quigg@sciproglobal.de
  • Expiry Date: 24 September 2023
  • Job Ref: 2023_08_25_1692946743

Expert Computer System Validation (CSV) (m/f/x) |Saxony

In this position you will be responsible for the planning, organization and implementation of the (re-)validation of the computer-aided systems (CSV) in cooperation with the process owners and the departments, especially IT. Additionally, you´ll be responsible for the creation and maintenance of validation (master) plans, requirements/risk analyses, test strategies and plans, work instructions and validation documents.


What will your tasks be as a ´Expert Computer System Validation (CSV) (m/f/x)´ be?

Responsibility for the planning, organization and implementation of the (re-)validation of the computer-aided systems (CSV) in cooperation with the process owners and the departments, especially IT.
Development and optimization of validation strategies and procedures for IT tools or IT infrastructure.
Responsible for the creation and maintenance of validation (master) plans, requirements/risk analyses, test strategies and plans, work instructions and validation documents.
Participation in regulatory inspections and internal/external audits
Implementation of training courses

Your requirements as ´Expert Computer System Validation (CSV) (m/f/x)´ be?

Successfully completed studies in the field of business informatics, information technology or engineering with a focus on computer science.
extensive experience in the development or implementation of IT systems; desirable in the pharmaceutical environment
Professional experience in the implementation of IT validation projects desirable
distinctive analytical, process-oriented as well as goal- and solution-oriented way of thinking and acting
Very good knowledge of German and English


Application process:

CV to my email c.quigg@sciproglobal.de
Call with a presentation of the company
I am your contact person for the entire application process (interviews to contract negotiations) i.e. You don't have to apply yourself
Discuss other exclusive positions that are tailored to your profile


My contact details:

c.quigg@sciproglobal.de
Tel: (direct dial) 089 2620 58 895
LinkedIn: https://www.linkedin.com/in/clodagh-quigg-b150b2200/
I look forward to your application!