Core Production Operations
Equipment Operation: Run machinery for weighing, dispensing, granulating, blending, drying, milling, tablet compression, capsule filling, and coating.
Batch Execution: Complete manufacturing steps according to Master Batch Records (MBRs) and Standard Operating Procedures (SOPs).
In-Process Checks: Perform and record routine quality tests on the shop floor, such as weight variation, hardness, and thickness checks.
Line Clearances & Changeovers: Clean, assemble, disassemble, and explicit lines between batches to prevent cross-contamination and downtime.
Quality and Compliance (cGMP)
Documentation: Maintain accurate, contemporaneous logs and batch production records (BPRs).
Quality Management: Support deviation handling, Change Controls, and Corrective and Preventive Actions (CAPAs).
Audit Readiness: Keep the facility, equipment, and personal hygiene standards ready for internal reviews and regulatory inspections (like USFDA).