Specialist, Pharmaceutical Production Documentation | Mitarbeiter (m/w/d) pharmazeutische Produktionsdokumentation

Cs2 ITEC GmbH Co. KG

Pfaffenhofen an der Ilm, Bayern, Deutschland
Published Dec 1, 2025
Full-time
No information

Job Summary

This role is ideal for a professional with a pharmaceutical background looking to specialize in production documentation compliance within an international environment. Day-to-day responsibilities focus on meticulous review and verification of all production data, ensuring strict adherence to manufacturing regulations (Herstellvorschriften). You will control data transfers between paper records and electronic systems (EDP), check entries for completeness and plausibility, and evaluate in-process control (IPC) results. A critical part of the job involves reviewing machine and device documentation, assessing batch balances, yields, and thoroughly documenting and commenting on disturbances, alarms, and quality-relevant diagnoses. The position requires a completed pharmaceutical vocational training (e.g., PTA or Pharmacist), experience with documentation review, and strong technical understanding of manufacturing processes. Success in this role demands a reliable, careful, and responsible work ethic, coupled with excellent German language skills (minimum B2 level) to support international projects.

Required Skills

Education

Completed training in a pharmaceutical profession (e.g., Certified Pharmacist or Pharmaceutical Technical Assistant)

Experience

  • Experience with the creation or review of pharmaceutical documentation
  • Theoretical knowledge in drug manufacturing
  • Practical experience in a pharmaceutical production facility (Ideally)

Languages

German (Fluent)

Additional

  • Reliable, responsible, careful, and flexible working style required.