24 Oct
|
KEC International
|
Ankleshwar
24 Oct
KEC International
Ankleshwar
To execute and supervise granulation activities in the Oral Solid Dosage (OSD) manufacturing area, ensuring compliance with Valuable Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), safety requirements, and production schedules while maintaining product quality and process consistency.
Execute wet granulation and dry granulation activities as per approved Batch Manufacturing Records (BMRs) and SOPs.
Handle and operate equipment such as Rapid Mixer Granulator (RMG), Fluid Bed Dryer (FBD), oscillating granulator, multimill, and other granulation equipment.
Ensure accurate dispensing verification, material charging, binder preparation, and granulation processing.
Monitor critical process parameters, including impeller speed, chopper speed, granulation time, binder addition, drying temperature, and Loss on Drying (LOD), as applicable.
Ensure proper drying, milling, sieving, and transfer of granules to the next manufacturing stage.
Verify equipment cleanliness, line clearance,
equipment status labels, and area readiness before starting operations.
Maintain and review BMRs, equipment logbooks, cleaning records, yield records, and other manufacturing documentation.
Follow cGMP, data integrity requirements, safety procedures, and applicable regulatory guidelines.
Coordinate with Quality Assurance (QA), Quality Control (QC), Warehouse, and Engineering departments to ensure smooth production operations.
Report deviations, breakdowns, process abnormalities, and yield variations to the reporting manager.
Ensure compliance with environmental, health, and safety requirements and maintain housekeeping in the granulation area.
Support investigations, CAPA implementation, process improvement, and audit readiness activities.
Guide and supervise granulation operators and production trainees, as assigned.
📌 Executive Production Ankleshwar
🏢 KEC International
📍 Ankleshwar