Position Summary
Responsible for reviewing activities performed in the Stability and Raw Material Laboratory to ensure compliance with current Good Manufacturing Practices (cGMP), pharmacopeial standards, and internal quality requirements. The role involves reviewing laboratory data, evaluating investigations, supporting software qualification activities, and driving compliance and continuous improvement initiatives.
Job Responsibilities
Ensure adherence to cGMP, Good Laboratory Practices (GLP), and data integrity requirements.
Review Analytical reports along with relevant documentation.
Evaluate laboratory errors, Out of Specification (OOS), and Out of Trend (OOT) results and recommend corrective actions.
Analyze non-conformance data and present trends through a dashboard.
Ensure awareness and compliance with equipment software requirements.
Support audit readiness through proper review and maintenance of laboratory documentation.
Contribute to proc...