Stability Program Coordinator

med-in.at

Unknown
Stability protocol drafting and review
Ich guidelines compliance
Sample chain-of-custody management
We aspire to be the premier research-intensive biopharmaceutical company delivering innovative health solutions that advance disease prevention and treatment in people and animals

Job Summary

  • We aspire to be the premier research-intensive biopharmaceutical company delivering innovative health solutions that advance disease prevention and treatment in people and animals.
  • The role involves drafting and maintaining stability protocols, managing sample logistics, performing data analysis, and ensuring compliance with regulatory and quality standards.
  • This position supports audit readiness, drives improvements in stability workflows, and collaborates cross-functionally with global teams to harmonize standards.

Matching Summary

We aspire to be the premier research-intensive biopharmaceutical company delivering innovative health solutions that advance disease prevention and treatment in people and animals.

Skills & Requirements

Must-have

  • Stability protocol drafting and review
  • ICH guidelines compliance
  • Sample chain-of-custody management
  • GLIMS system proficiency
  • GMP and GDP adherence
  • Stability data trend analysis
  • Audit and inspection readiness

Nice-to-have

  • Lean Six Sigma experience
  • Statistical literacy for trend analysis
  • Digitalisation and KPI reporting
  • Cross-functional collaboration
  • Self-motivated and flexible work style
  • Continuous quality improvement
  • Data integrity principles knowledge

Key Requirements

  • Degree in Science, Technical, or Quality field
  • 4 years biotechnology/pharmaceutical experience
  • Understanding of cGMP laboratory operations
  • Knowledge of ICH, USP, and global compendia regulations
  • Proven cross-functional teamwork
  • Ability to manage multiple priorities
  • Not specified work authorization

Work Rights

Not specified

Tailored Resume

Cover Letter