Company Overview
Role Purpose
Academic Stream
Work experience (in months)
Job Responsibility and key Decisions
Perform Stability Sample Testing
Conduct routine and nonroutine testing on drug substance or product samples pulled from stability chambers.
Ensure testing follows current SOPs, methods, and approved protocols.
Document Test Results
Record all observations and results accurately in realtime.
Ensure completeness and traceability of data for review and audit readiness.
Assist in Investigation and Troubleshooting
Support OOSOOT Out of SpecificationOut of Trend investigations by providing accurate test data.
Participate in lab incident investigations under guidance.
Sample Management
Label, log, and handle stability samples according to protocols.
Ensure correct sample storage, tracking, and timely testing.
Support Regulatory Compliance
Ensure compliance with ICH stability guidelines and internal quality standards.
Participate in internal or regulatory audits as required.
Coordination with Stability Program Management
Work closely with the stability team to understand the testing schedule and sample pulls.
Ensure no missed time points or delays in testing.
Training and SOP Adherence
Complete required training on stability procedures, SOPs, and analytical techniques.
Follow only approved and current versions of documents and methods.
DecisionMaking Scope
Make routine decisions regarding daytoday testing priorities.
Escalate deviations, instrument issues, or unexpected results to supervisors immediately.