Stability Program Coordinator

Mayoly

Stability protocols and amendments
Stability study design parameters
Glims verification and status tracking
We aspire to be the premier research-intensive biopharmaceutical company, at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals

Job Summary

  • We aspire to be the premier research-intensive biopharmaceutical company, at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.
  • Responsibilities include drafting, reviewing, and maintaining stability protocols, defining study designs, managing stability pulls, and performing data analysis and trend interpretation.
  • Ensure adherence to GMP, GDP, data integrity, and site/global SOPs, while investigating deviations and supporting audits.

Matching Summary

We aspire to be the premier research-intensive biopharmaceutical company, at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

Skills & Requirements

Must-have

  • Stability protocols and amendments
  • Stability study design parameters
  • GLIMS verification and status tracking
  • Stability data compilation and trend analysis
  • GMP, GDP, and data integrity adherence
  • Investigate OOS/OOT/atypical trends

Nice-to-have

  • Continuous quality/process improvement
  • Interdependent work culture
  • Digitalization efforts and KPI reporting

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