Executive

Role & responsibilities

Online monitoring of QC analysis along with respective raw data.

Review of Analytical test reports of Raw Material, Packing Material, In process, Finished Product, Stability & Working std.

Review of analytical testing reports of validation, hold time study , cleaning validation, method validation, method verification.

Final review of finished product COA along with raw data.

Review of Master Raw Material, Packing Material, In process, Finished Product, Stability specification, MOA, Test Protocol, and Test Report.

Monitoring for withdrawal and analysis of stability samples as per planner.

Monitoring of stability chamber related activities.

Monitoring the calibration of QC instruments as per planner and according with respective SOP and ensuring completion and compliance of calibration report.

Responsible for review of QMS documents (change control, deviation, incident, investigation).

Responsible for initiation of Change control, Deviation, Incident and CAPA.

Responsible for initiation of document Ratification and Errata.

Responsible for investigation of OOS, OOT, incidents of the QC laboratory.

Review of metadata & Audit trail in software as well as in report.

To ensure maintenance of data integrity of Documents and Systems.

Responsible for compliance of cGMP norms.