Job
Description
Role & responsibilities Online monitoring of QC analysis along with respective raw data. Review of Analytical Test Reports for Raw Material, Packing Material, In-Process, Finished Product, Stability, and Working Standards. Review of analytical testing reports for validation, hold time study, cleaning validation, method validation, and method verification. Final review of Finished Product COA along with raw data. Review of Master Specifications for Raw Material, Packing Material, In-Process, Finished Product, Stability, MOA, Test Protocols, and Test Reports. Monitoring the withdrawal and analysis of stability samples as per the planner. Oversight of stability chamber-related activities. Monitoring the calibration of QC instruments as per the planner and SOPs, ensuring compliance and completion of calibration reports. Responsible for the review of QMS documents, including Change Control, Deviation, Incident, and Investigation. Initiation of Change Control, Deviation, Incident, and CAPA. Responsible for initiation of document Ratification and Errata. Investigation of OOS, OOT, and incidents in the QC laboratory. Review of metadata & Audit Trail in software as well as reports. Ensuring the maintenance of data integrity for documents and systems. Compliance with cGMP norms and regulatory requirements.
