30 Aug
|
Amneal Pharmaceuticals
|
Dahej
30 Aug
Amneal Pharmaceuticals
Dahej
Essential Functions:
- Robust experience in solid-phase and liquid-phase peptide synthesis.
- Knowledge of hybrid technologies / Molecular Hiving preferred.
- Hands-on experience in process development of peptide pharmaceuticals.
- Exposure to scale-up processes will be an added advantage.
- Operate and monitor equipment used in various stages of API production such as reactors, centrifuges, dryers, millers, sifters, etc.
- Ensure cleanliness and readiness of equipment before batch charging through visual verification procedures.
- Maintain accurate records, including Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR), equipment usage logs, and deviation reports.
- Execute batch operations strictly as per SOPs and GMP guidelines.
- Monitor and record process parameters in real-time to ensure adherence to specifications and quality.
- Report and coordinate with Engineering for any equipment breakdowns during the shift.
- Coordinate with QA for issuance and submission of documents and with the warehouse for material movement.
- Handle raw materials, intermediates, and APIs, ensuring proper storage, reconciliation, and documentation.
- Follow standard procedures for sampling and in-process testing of materials and intermediates.
- Maintain cleanliness and good housekeeping in the designated manufacturing area.
- Monitor utilities in the plant (e.g., steam, vacuum, chilled water) and report abnormalities.
- Monitor and record environmental conditions like temperature, humidity, and differential pressure in clean areas (Level-I, II, III).
- Perform daily verification and calibration checks of weighing balances.
- Participate in periodic equipment cleaning and preventive maintenance.
- Ensure proper handling and disposal of hazardous materials as per environmental guidelines.
- Identify process deviations, malfunctions, or quality concerns and report them immediately.
- Support continual improvement by suggesting ideas for optimizati
📌 Manager, Manufacturing Api (Dahej)
🏢 Amneal Pharmaceuticals
📍 Dahej