Review of analytical data of FG, RM, Stability, process validations etc.
as per specification and qualification documents. Review of protocols for stability study, hold time study, qualification/ calibration of QC instruments /software, stability trend data.
To issue OOS/OOT format, co-ordinate OOS/OOT investigation related to QC and prepare review /approve investigation report.
Review specifications and inspection plan in SAP as per specification documents. Review RM code to code notification & assign task.