Stability Program Coordinator

Muckelab

Unknown
Stability protocol management
Ich guidelines compliance
Gmp and gdp adherence
We aspire to be the premier research-intensive biopharmaceutical company delivering innovative health solutions for people and animals

Job Summary

  • We aspire to be the premier research-intensive biopharmaceutical company delivering innovative health solutions for people and animals.
  • The role involves drafting and maintaining stability protocols, managing sample logistics, performing data analysis, and ensuring compliance with global regulatory standards.
  • The coordinator will serve as the site stability point-of-contact, support audits, drive workflow improvements, and collaborate cross-functionally with QC, QA, Supply Chain, and global teams.

Matching Summary

We aspire to be the premier research-intensive biopharmaceutical company delivering innovative health solutions for people and animals.

Skills & Requirements

Must-have

  • Stability protocol management
  • ICH guidelines compliance
  • GMP and GDP adherence
  • Stability data trend analysis
  • Sample chain-of-custody oversight
  • Quality Management System document control
  • Cross-functional collaboration

Nice-to-have

  • Lean Six Sigma experience
  • GLIMS proficiency
  • Statistical literacy for trend analysis
  • Digitalisation and KPI reporting support
  • Flexible and self-motivated work culture
  • Continuous quality/process improvement

Key Requirements

  • Degree in Science/Technical/Quality or related field
  • 4 years’ experience in biotechnology or pharmaceutical industry
  • Understanding of cGMP for Laboratory Operations
  • Knowledge of GMP, ICH, USP and global compendia regulations
  • Demonstrated quality/process improvement skills
  • Ability to work independently and in teams

Work Rights

Not specified

Tailored Resume

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