- Perform systematic inspections of the line, area, and equipment before starting any manufacturing operation (dispensing, granulation, compression, coating, or packaging).
- Verify raw material labels, clean balances, and check calculated API and ingredient quantities
- Perform foil/material matching, overprinting verification (batch code, expiry), leak testing of blisters/strips, and correct count reconciliation.
- Collect and pull composite, in-process, finished product, control/retained, and stability samples according to established SOP protocols
- Draft and compile the Annual Product Quality Review reports for all assigned OSD products.
- Ensure that the APQR conclusions meet regulatory guidelines.