medac group

Global QA Manager – Computer System Validation

medac group

full-time

Posted on:

Location Type: Hybrid

Location: Wedel • Germany

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About the role

  • Responsibility for implementing global policies for the validation of computerized systems and data integrity within the medac group
  • Assume responsibility for and perform computer system validation at the Dessau production site (oncotec, approx. 2 years)
  • Support group members in performing computer system validations
  • Ensure implementation of the global requirements for validation of computerized systems and data integrity within the medac group
  • Further develop methods for computer system validation and data integrity in coordination with the Global Process Owner and the Head of Global QA Systems
  • Responsible for ensuring the validated status of the medac group's global GxP-relevant IT systems
  • Prepare and revise the related global documentation in coordination with the Global Process Owner
  • Conduct various training sessions

Requirements

  • Degree in natural sciences, computer science, engineering, or a comparable qualification
  • Ideally practical professional experience in a GMP environment and very good knowledge of the GAMP guidance (GAMP 5®)
  • Knowledge of the Veeva platform desirable
  • Willingness to work at our Dessau production site (oncotec) during the first two years of employment
  • Solid IT skills (e.g., Word, Excel, PowerPoint, databases) and an affinity for IT
  • Solution-oriented, structured, and independent way of working
  • Team player, flexible, decisive, and able to understand cross-functional pharmaceutical processes
  • Fluent German and English skills, both written and spoken
Benefits
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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
computer system validationdata integrityGMPGAMP 5IT systems validationdocumentation preparationtraining facilitation
Soft Skills
solution-orientedstructured workingindependent workingteam playerflexibledecisivecross-functional understanding