* 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 – Robust 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.