Stability Program Coordinator

microsatsystems.biz

Stability protocols and amendments
Stability study design parameters
Stability pull schedules execution
We use the power of leading-edge science to save and improve lives around the world

Job Summary

  • We use the power of leading-edge science to save and improve lives around the world.
  • Draft, review, and maintain stability protocols and amendments in alignment with ICH guidelines, internal SOPs, and regulatory commitments.
  • Own and drive improvements in stability workflows, scheduling, chamber utilization, and data visualization.

Matching Summary

We use the power of leading-edge science to save and improve lives around the world.

Skills & Requirements

Must-have

  • Stability protocols and amendments
  • Stability study design parameters
  • Stability pull schedules execution
  • Sample chain-of-custody management
  • GLIMS verification and tracking
  • Stability data trend analysis

Nice-to-have

  • Continuous quality/process improvement
  • Interdependent work culture
  • Embracing digitalization efforts

Key Requirements

  • 4 years' experience in biotech/pharma
  • Degree in Science/Technical/Quality
  • Understanding of cGMP requirements
  • Understanding of GMP, ICH, USP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter