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Unknown company is seeking personnel to set up, calibrate, and operate core granulation equipment, including RMG, FBD, and vibro sifters, in a strictly controlled manufacturing environment. The role requires following BMR/BPR/SOPs, maintaining detailed logbooks, and ensuring total batch traceability.
You will monitor critical process variables and perform line clearance to prevent cross-contamination. Candidates should be familiar with cGMP, GDP, and EHS guidelines, and possess strong
Set up, calibrate, and operate core granulation machinery, including Rapid Mixer Granulators (RMG), Fluid Bed Dryers (FBD), Multi-Mills, and Vibro Sifters.
Execute wet or dry granulation processes strictly following Batch Manufacturing Records (BMR), Batch Production Records (BPR), and Standard Operating Procedures (SOPs).
Verify, weigh, load, and premix raw materials and binders into granulators according to exact formulation ratios.
Monitor process variables (such as binder spray rate, drying temperatures, moisture content, and loss-on-drying) and perform particle size distribution checks to ensure granule uniformity.
Perform rigorous line clearance procedures before and after every batch to prevent cross-contamination between different product lines.
Adhere to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and Environmental Health and Safety (EHS) guidelines at all times.
Maintain detailed, real-time logbooks, equipment status tags, and BMR entry records to ensure total batch traceability.
Wash, sanitize, and assemble all product contact parts, tanks, and processing suites according to strict hygiene standards.
Identify operational abnormalities, assist with routine equipment maintenance, and report any process deviations immediately to quality control and supervisors.