- Prepare Stability Summary Reports (SSR) and related stability documentation.
- Track stability study status, report timelines, and documentation activities.
- Maintain stability records, reports, and supporting documents in an organized manner.
- Review stability data and documentation for completeness and accuracy.
- Coordinate with QC, QA, and cross-functional teams for data collection, review, and approval of SSRs.
- Ensure timely updates, document revisions, and archival of stability documents.
- Maintain documentation compliance as per GMP, GDP, and regulatory requirements.
Support audit and inspection requirements by providing stability documentation and records.
Required Skills:
- Stability Documentation & SSR Preparation – Ability to prepare accurate and compliant Stability Summary Reports.
- Document Tracking & Record Management – Solid skills in maintaining and monitoring stability documentation status.
- GMP/GDP Documentation Practices – Understanding of regulated documentation requirements.
- Data Review & Accuracy – Ability to verify stability data and ensure completeness of reports.
- Coordination & Timeline Management – Effective follow-up with teams to ensure timely completion of stability documents.