Junior Qualification and Validation Specialist (Quality Assurance) | Junior-Mitarbeiter (m/w/d) Qualifizierung/Validierung im Bereich Qualitätssicherheit

TYC Personalmanagement Gerlinde Tyc

Pfaffenhofen an der Ilm, Bayern, Deutschland
Published Jul 11, 2025
Full-time
No information

Job Summary

This role is an exciting opportunity for a Junior Qualification and Validation Specialist to join a global pharmaceutical company in Pfaffenhofen an der Ilm, Germany. The successful candidate will play a crucial role in supporting the Quality Management department during the project phase, specifically focusing on qualification and validation activities within new construction projects like BioDS and F5 Bioconjugation. Day-to-day tasks will involve reviewing and creating essential documentation such as URS, risk analyses, traceability matrices, and validation plans. You will also be responsible for reviewing and approving qualification and validation documents (DQ, IQ, OQ, PQ) and contributing to the validation of software and computer-aided systems, ensuring compliance with current guidelines like GxP, 21CFR11, and GAMP5. This position is ideal for someone with a strong quality mindset and a desire to ensure regulatory compliance and high-quality standards in a pharmaceutical GMP environment.

Required Skills

Education

Completed natural science or technical vocational training (minimum 3 years, e.g., Pharmacy, Chemistry, Biology)

Experience

  • Relevant professional experience in qualification and validation
  • Knowledge and experience in equipment qualification and Computer System Validation (CSV) in a pharmaceutical GMP environment (desirable)

Languages

German (Fluent)English (Fluent)

Additional

  • Not specified