03 Aug
|
Aragen Life Sciences
|
Hyderabad
03 Aug
Aragen Life Sciences
Hyderabad
Responsible for executing API manufacturing operations, maintaining GMP-compliant documentation, handling GLR and SSR activities, and ensuring protected and effective production as per approved procedures and regulatory requirements.
Key Responsibilities
Production Operations
Execute API manufacturing processes including charging, reactions, distillation, filtration, centrifugation, drying, milling, and packing.
Monitor and record critical process parameters during batch execution.
Operate and monitor reactors, centrifuges, ANFDs, dryers, and associated equipment.
Ensure adherence to Batch Manufacturing Records (BMR) and production schedules.
Documentation & GMP Compliance
Maintain and review Batch Manufacturing Records (BMR),
Batch Packing Records (BPR), equipment logbooks, and cleaning records.
Prepare, review, and maintain General Log Records (GLR) and ensure accurate documentation practices.
Generate and verify Shift Summary Reports (SSR) for daily production activities.
Ensure compliance with cGMP, GDP, SOPs, and regulatory guidelines.
Perform line clearance and document verification before batch initiation.
Support deviation investigations, CAPA implementation, change controls, and incident reporting.
📌 Production Chemist Hyderabad
🏢 Aragen Life Sciences
📍 Hyderabad