QC Stability - Sr. Officer
QC Stability - Sr. Officer
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Job Description
Stability Study Management: Conduct and manage accelerated longterm and ongoing stability studies ensuring adherence to approved protocols and schedules.
Sample Handling: Ensure proper storage pulling and tracking of stability samples from stability chambers and maintain accurate inventory.
Analytical Testing: Perform stability testing using HPLC GC UV and other analytical techniques ensuring accurate and reproducible results.
Documentation & Reporting: Prepare and review stability protocols summary reports trend data and analytical results in compliance with GMP GLP and data integrity standards.
OOS/OOT Investigations: Support or lead OOS/OOT investigations deviation handling and CAPA implementation.
Regulatory & Audit Support: Ensure all documentation is auditready and supports regulatory submissions (USFDA MHRA WHO EUGMP) and inspections.
Coordination: Collaborate with crossfunctional teams including QA RA and Product Development for data sharing and compliance activities.
Required Experience:
Senior IC
Employment Type
Full-Time
