About this role
Supervise operation of API manufacturing equipment such as:
Reactors
Centrifuges
Nutsche filters / Filter dryers
ANFD
Vacuum/agitated dryers
Distillation systems
Solvent recovery systems
Milling and sieving equipment
Identify equipment abnormalities and coordinate with Engineering for timely resolution.
Monitor equipment utilization and minimize production downtime.
Ensure equipment is properly cleaned, labeled, and released before use.
Take complete responsibility for API manufacturing operations during the assigned shift.
Execute production batches as per approved BMRs, SOPs, and validated process parameters.
Monitor and control critical process parameters such as:
Temperature
Pressure
Vacuum
pH
Agitation
Addition rate
Reaction time
Drying parameters
Supervise operations including charging, reaction, heating/cooling, extraction, filtration, centrifugation, distillation, solvent recovery, drying, milling, and packing, as applicable.
Ensure all manufacturing activities are performed in compliance with cGMP, SOPs, BMRs, GDP, and data-integrity requirements.
Review and ensure proper completion of BMRs, equipment logbooks, cleaning records, and shift records.
Ensure proper line clearance, equipment status labeling, area clearance, and cleaning verification.
Report and support investigation of
Deviations
Process abnormalities
Yield variations
Equipment failures
Batch failures
Support OOS/OOT, deviation, CAPA, change-control, and investigation activities wherever applicable.
Ensure production records are complete, accurate, and available for QA review.
Coordinate with QA/QC for sampling, testing, line clearance, process checks, and batch-related activities.
Coordinate with Engineering/Maintenance for equipment breakdowns and technical problems.
Coordinate with Warehouse for raw materials, solvents, and packing materials.
Coordinate with EHS for safety-related activities and emergency situations.
Ensure effective communication with the incoming/outgoing shift regarding batch status, equipment condition, pending activities, and abnormalities.
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