Representative QA Operations Qualification | Biologe (m/w/d)

Daiichi Sankyo Europe GmbH

Pfaffenhofen an der Ilm, Bayern, Deutschland
Published Aug 19, 2025
Full-time
No information

Job Summary

This role involves contributing to the qualification of facilities, equipment, and utility systems, as well as analytical devices and computer-aided laboratory systems, in a GMP-regulated environment. The successful candidate will participate in the validation of software and computer-aided systems according to current guidelines, working across all phases of qualification and validation projects (DQ, IQ, OQ, PQ). Key responsibilities include creating and maintaining validation and qualification documents, assessing change requests for GMP compliance, ensuring adherence to regulatory requirements, and preparing documentation for authority inspections. This position offers an opportunity to work within a global pharmaceutical company dedicated to improving patient lives, focusing on quality assurance in a dynamic and interdisciplinary setting.

Required Skills

Education

Completed scientific degree or comparable training

Experience

  • Initial practical QA experience in a GMP-regulated environment with a focus on qualification and validation (including CSV)
  • Experience in pharmaceutical sterile production is an advantage

Languages

German (Fluent)English (Fluent)

Additional

  • Not specified