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Amneal Pharmaceuticals

Associate Manufacturing Operations Specialist

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  • 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

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