Stability Program Coordinator

Mdcrecruiting

Unknown
Stability protocol development
Ich guideline compliance
Controlled document lifecycle management
We aspire to be the premier research-intensive biopharmaceutical company delivering innovative health solutions that advance disease prevention and treatment for 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 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 support audit readiness, collaborate across departments, and drive improvements in stability workflows and data visualization.

Matching Summary

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

Skills & Requirements

Must-have

  • stability protocol development
  • ICH guideline compliance
  • controlled document lifecycle management
  • sample chain-of-custody management
  • GLIMS system proficiency
  • GMP and GDP adherence
  • data integrity and metadata accuracy

Nice-to-have

  • Lean Six Sigma experience
  • statistical literacy for trend analysis
  • cross-functional collaboration
  • digitalisation and KPI reporting support
  • flexible and self-motivated work style
  • continuous quality improvement tools

Key Requirements

  • Degree in Science/Technical/Quality or related field
  • 4 years experience in biotechnology or pharmaceutical industry
  • understanding of cGMP laboratory operations
  • knowledge of GMP, ICH, USP, and global compendia regulations
  • demonstrated quality/process improvement skills

Work Rights

Not specified

Tailored Resume

Cover Letter