1. Environmental monitoring of manufacturing clean room area.
2. Non-viable particle monitoring of manufacturing clean room area.
3. Compressed air /nitrogen gas monitor and Personnel monitoring.
4. To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g. plates, swabs, etc.
5. To perform line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labelling and packing.
6. To perform Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP.
7. Perform Root Cause Analysis using tools such as Fishbone, KT, 5Whys, etc.