1. Responsible for providing line clearance prior to Manufacturing, and Packaging and Validation activity during Batch and Product change over.
2. Responsible for sampling and in process checks as per defined frequency and methodology during batch manufacturing of routine Commercial batches, Validation batches and Exhibit batches.
3. Responsible for ensuring the closure of Quality event (Incident/Deviation/Temporary Change Control/OOS) associated with manufactured batch before the batch release.
4. Responsible for verification of calibration and cleaning of manufacturing & warehouse equipment.
5. Responsible for collection of swab/rinse samples for micro/chemical analysis and recovery study.
6. Responsible for ensuring timely submission of the samples to the QC for analysis.
7.
Responsible for co-ordinating F&D; in technology transfer during exhibit/engineering batch manufacturing.
8. Responsible for review of manufacturing & Warehouse area log books and environmental monitoring records.
9. Responsible for ensuring status labelling, segregation of the materials as per desired storage conditions.
10. Responsible to ensure segregation of the rejected material and secure disposal of the same.
11. Responsible for Management of retain sample room, registration, visual inspection and destruction of finished product control samples in LIMS and environmental monitoring for retain sample room.
12. Responsible for review of executed & Master BMR and BPR and release.