Senior Officer

Amneal Pharmaceuticals

2 - 7 years

5 - 9 Lacs

dahej

Posted:1 hour ago| Platform:

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Skills Required

lean manufacturing manufacturing process process improvement shop floor packaging inventory control gmp troubleshooting preventive maintenance material handling

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 maintece.
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 optimization, efficiency, and waste reduction.
Take mandatory safety and operational training via AIMS software and participate in hands-on skill-building sessions.
Adhere strictly to safety practices and use PPE as per company safety protocols.
Participate in emergency response activities such as managing spills or operational incidents.
Ensure timely inventory of plant/process-related consumables.
Review completed manufacturing records for accuracy, completeness, and compliance with SOPs.

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