**Summary**:
- Supports the follow up of local - regional processes, procedures and activities related to stability studies life cycle management, required for drug product control, preserving compliance of local, regional and global quality standards as delegated to QOP, and any data analysis required such as trend reports.
**About the Role**:
**Major accountabilities**:
- Assure stability studies implementation, fulfilling local and international guidelines and standards (such as NOM-073, RE n°*******).
- Safeguard the execution of activities related to the development of protocols and stability reports, as well as trend analysis (implementation and maintenance of statistical analysis), sample calculation, sample entry to stability chambers, and management of analytical results of samples corresponding to stability studies, according to study requirements and the corresponding climatic zone.
- Guarantee according to study requirements, internal or third par...