10 Aug
|
Amneal
|
Bharuch
Description
Essential Functions:
• Strong 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 valuable 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
📌 Manager, Manufacturing API (Bharuch)
🏢 Amneal
📍 Bharuch