Stability Program Coordinator

vetshired.us

Unknown
Stability protocol drafting and review
Ich guidelines compliance
Controlled document lifecycle management
We aspire to be the premier research-intensive biopharmaceutical company delivering innovative health solutions for people and animals worldwide

Job Summary

  • We aspire to be the premier research-intensive biopharmaceutical company delivering innovative health solutions for people and animals worldwide.
  • The role involves drafting and maintaining stability protocols, managing sample logistics, ensuring compliance with GMP and regulatory standards, and supporting audit readiness.
  • The Stability Program Coordinator partners with global teams and drives improvements in workflows, data visualization, and harmonization with global standards.

Matching Summary

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

Skills & Requirements

Must-have

  • Stability protocol drafting and review
  • ICH guidelines compliance
  • Controlled document lifecycle management
  • Sample chain-of-custody and storage management
  • GMP and GDP adherence
  • Data integrity and metadata accuracy
  • Trend analysis and stability data interpretation

Nice-to-have

  • Lean Six Sigma experience
  • GLIMS proficiency
  • Statistical literacy for trend analysis
  • Cross-functional collaboration
  • Digitalisation and KPI reporting support
  • Flexible and self-motivated work culture

Key Requirements

  • Degree in Science/Technical/Quality or related field
  • 4 years experience in biotechnology or pharmaceutical industry
  • Understanding of cGMP and ICH regulations
  • Excellent communication skills
  • Ability to work independently and in teams
  • Demonstrated continuous quality improvement knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter