Senior Officer, QC Technical Writer

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.