Job Description

JOB DESCRIPTION

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 – Strong 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.

Senior Officer, QC Technical Writer

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