Ensure online checking of environmental monitoring records in batch documents and logbooks.
Ensure daily and monthly calibration of balances as per cGMP requirement.
Coordinate with dispensing, warehouse, IPQA team for timely execution of batches as per schedule.
Carry out manufacturing activity as per BMR instruction.
Verify and crosscheck dispensed raw materials and semifinished goods prior to the start of batch processing.
Ensure online documentation during batch processing (e.g., verifying weights on balances, recording machine parameters, performing inprocess tests).
Ensure critical process in manufacturing activity such as Correct sieve selection as per BMR, granulation end point determination, LOD checking, blending time, Blender RPM, machine setting parameters, in process testing are followed correctly.
Ensure that all critical operations are performed only by trained operators and no casual manpower is assigned for any critical operations.
Ensure completion of training for operators and contract manpower before start of work.
Ensure proper quarantine and arrangement of all IPC samples and clean equipment.
Ensure and maintain the inventory for the equipment in each section respectively.
Monitor implementation of safety practices and work discipline at shop floor during work.
Perform audit trail review and electronic data review as per SOP.
Review temperature and humidity excursion record.
Review and verify correctness of the display SOP list.
Verify SAP status labels for data accuracy.
Ensure cleanliness of area and equipment before IPQA line clearance.
Prepare shift schedules and Issue bulk material ready for packing.
Ensure dust generation is minimized.
Ensure online batch completion and reconciliation.
Always maintain the shop floor in an auditready condition and ensure all machines operate as per defined norms.
Conduct required shopfloor training and complete all assigned training tasks within the defined timelines.
Verify and send nonrecoverable material, remaining blend, and solutions to scrap with proper labelling.
Monitor, supervise, and train contract manpower for identification of tablet defects during tablet inspection.
Initiate maintenance requests for equipment under breakdown and track closure.
DESIRED SKILLS
Handson exposure to all stages of oral solid dosage (OSD) manufacturing.
Exposure to latest manufacturing technologies and equipment.
Proficiency in SAP for production-related transactions.
Strong technical skills for shopfloor troubleshooting.
Effective managerial and leadership capabilities.
Excellent communication and problem-solving abilities.
Should be assertive, proactive, and self-driven.
Ability to work effectively in a dynamic environment.
Strong crossfunctional coordination abilities.
Focused on driving action plans to achieve set targets.
