- Responsible for review and approval of Master Formula Record.
- Responsible for review of completed batch record.
- Authorized for release/rejection of the Finished products as a Qualified Person, after reviewing all the quality record. (Batch Manufacturing and Packing records, In-process Quality Control records, analytical records, OOS and Certificate of analysis).
- Authorized for review and approval of Batch Manufacturing Records and packing Records.
- Programming and placing data loggers to consignment/shipments based on mail confirmation from the international operation team.
- Responsible for review and approval of the Annual Product Quality Review.
- Responsible for cross verification of RM & PM process order against batch record.
- Responsible for verification of raw materials as per process order during dispensing.
- Responsible for giving line-clearance for different stages of the manufacturing process.
- Responsible for cross verification of the materials with process order as a part of Line clearance for production activity.
- Responsible for release to intermediate stages during Manufacturing.
- Responsible for collection and submission of the analysis samples, control samples, stability samples and process validation samples or any other samples (as required).
- Responsible for terminal inspection in FG.
- Responsible for verification of production documents & log sheets (calibration, Area temperature etc.) in respective areas.
- Responsible for Checking in-process activity in manufacturing, packing stages as per BMR & BPR instructions.
- Responsible for periodic calibration of In-process instruments like Friabilator, DT apparatus, weighing balance, pH meter etc.