1. Preparation of SOP, related to Quality Assurance & manufacturing activities.2. Handling of Change Control, follow up and closure .3. Handling of Deviation.4. Handling of Risk Assessment of process and equipment5. Handling of vendor Qualification documents and its maintenance like Quality information record, Initial provisional consignment to store, Vendor code maintenance, material code maintenance.6. Preparation of Approved Vendor List.7. Preparation of Annual Product Quality Review.8. Supervise the QA activities of Manufacturing Plant.9. Preparation of qualification documents of equipment.10.prearation of CAPA summary report on monthly basis for follow up and closure.

*Handling of Quality Management System -Change management system-Handling of Deviation-Preparation of APQR-Handling of CAPA-Handling of market complaint-Handling of Non compliance Report (NCR)-Handling of Documents Rectification Form-Preparation of samary for Change control, Deviation, market complaint.

1. Preparation of SOP, related to Quality Assurance & manufacturing activities.2. Handling of Change Control accordingly ICH Q10 guideline ,Change Control impact assessment, approval, execution and effectiveness verification 3. Handling of Deviation accordingly ICH Q10 guideline.4. Handling of Risk Assessment Accordingly ICH Q9 guideline5. Handling of vendor Qualification documents and its maintenance like Quality information record, Initial provisional consignment to store, Vendor code maintenance, material code maintenance.6. Preparation of Approved Vendor List.7. Artwork Approval by 21 CFR compliance Goose software by coordination with IRA department8. Preparation of Annual Product Quality Review.9. Supervise the QA activities of Manufacturing Plant.

1 Maintenance of Daily documentation like: Daily area log, M/c and equipment log2. Preparation of BMR/BPR & its Issuance.3. Review & check the BMR for its compliance as per the requirement.4. Issue & retrieval of BMR/BPR, FORMATS, PROTOCOL, & all related Documents to concern departments. 5. In-process checking & control of data entries in Tablet, Capsule & packing6. Updating of document initiation form, distribution form, closure, follow up.7. Calibration of instrument like WEIGHING BALANCE, D.T, FRIABILITY Apparatus8. Monitoring and sampling of all stages of process validation batches, preparation & Report compilation of PVP, PVR..9. Line clearance at every stage & in process checks during Manufacturing and Packing activities as per BMR/BPR for tablets, capsules.10. Involved in execution of internal quality audits and compliance audit for the closure of the audit findings and vendor qualification.11. Collect and maintain the record the retain sample of finish goods by following standard operating procedures.