- Responsible for Review of Executed Batch Manufacturing records/ECR and Analytical records.
- Responsible for Sampling of Finished product and its respective records, withdrawal of stability sample, hold time sample and other sample as required.
- Responsible for Monitoring of packing/repacking related activities and its respective records.
- Responsible for Verification of Dispatch activities and QR code approval related records.
- Responsible for Ensure that complies with existing SOPs, cGMP/cGLP & plant round.
- Responsible for Generation, issuance, and control of label.
- Responsible for Preparation and review of PQR of product.
- Responsible for Preparation of SOPs and Equipment Qualification protocol and report.
- Responsible for Change control issuance, reviewed and evaluation.
- Responsible for Verification of external calibration and certification records.
- Responsible for to attend training programs organized by the company for continuous training and up gradation of knowledge for complies with existing cGMP/cGLP/safety/IMS guidelines and other relevant information.
- Responsible for Preparation of process validation and cleaning validation protocol and report.
- Responsible for Calculation to OOT (Out of trend)
- Responsible for perform other work allocated by Designated person.
- Responsible for prepared the deviation investigation report.