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Associate Manufacturing Operations Specialist
Job description
Perform line clearance before starting compression activities. Verify cleanliness and status labels of compression machine, tooling, and accessories. Ensure availability of approved Batch Manufacturing Record (BMR). Verify granules/blend details and status labels before use. Install and set up punches, dies, and turret as per product requirements.
Operate tablet compression machine according to approved parameters. Adjust machine settings for tablet weight, hardness, thickness, and compression force. Monitor critical process parameters during compression. Perform and record in-process checks at specified intervals. Ensure tablet appearance, weight variation, thickness, friability, and hardness are within specifications.
Collect samples for in-process testing as per BMR. Minimize tablet defects such as capping, lamination, sticking, picking, and chipping. Reconcile product quantities during and after batch completion. Complete all BMR entries accurately and in real time. Maintain equipment usage and logbook records. Follow Good Documentation Practices (GDP) and Data Integrity requirements.
Prevent mix-up and cross-contamination during operations. Clean compression machine, punches, dies, and area after batch completion. Report deviations, machine breakdowns, and abnormalities immediately. Follow cGMP, safety requirements, and wear appropriate PPE. Maintain housekeeping and cleanliness in the compression area.
Ensure product quality, safety, and regulatory compliance throughout the compression process. ITI/ Diploma
Description copied from Amneal Pharmaceuticals's careers page. Read the full posting before you apply.
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