Execute batch manufacturing activities as per approved Batch Manufacturing Records (BMRs), SOPs, and production plans. Operate and monitor API manufacturing processes, including reaction, filtration, centrifugation, drying, blending, micronization, and packing. Ensure adherence to process parameters and promptly escalate any deviations or abnormalities. Coordinate with shift teams to ensure smooth production operations and optimum equipment utilization. Verify material availability and coordinate with warehouse personnel for timely issuance and reconciliation. Ensure accurate and timely completion of BMRs, logbooks, equipment usage records, and other GMP documents. Comply with cGMP, GDP, data integrity requirements, and site quality standards. Support investigations related to deviations, incidents, OOS/OOT, and implement CAPAs. Follow approved SOPs and ensure adherence to regulatory requirements.
