Senior Officer, QC Technical Writer
On-siteAhmedabad, Gujarat, India
Ahmedabad, Gujarat, IndiaOn-siteFull TimeSenior LevelBachelors DegreeHealthcare TechLarge
Full TimeSenior LevelBachelors DegreeLargeHealthcare Tech
Job Summary
Prepare Stability Summary Reports (SSR) and related stability documentation, tracking study status, timelines, and activities. Maintain organized records and review data for completeness and accuracy per GMP, GDP, and regulatory requirements. Coordinate with QC, QA, and cross-functional teams for data collection, review, and approval of SSRs, ensuring timely updates, revisions, and archival. Support audit and inspection requirements by providing stability documentation and records.
Required Qualifications
- 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
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