02 Aug
|
Aragen Life Sciences
|
Hyderabad
02 Aug
Aragen Life Sciences
Hyderabad
Responsible for executing API manufacturing operations, maintaining GMP-compliant documentation, handling GLR and SSR activities, and ensuring protected and efficient 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