Deputy Manager / Manager - Production Injectable

Department Icon Operations Maintenance & Support
Posted: 1 year ago
10-15 years
Jadcherla
Operations Maintenance & Support
work from office
Full Time

Posted: 1 year ago
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Posted over 15 days ago, so the role may have closed. Confirm on the employer's page when you apply, or see similar jobs.

Job Description

1. Production Operations

  • Plan, execute, and monitor day-to-day injectable manufacturing operations (Liquid / Lyophilized / SVP / LVP).
  • Ensure adherence to batch manufacturing records (BMR) and standard operating procedures (SOPs).
  • Coordinate with Planning, QA, QC, Engineering, and Stores for smooth production activities.
  • Monitor in-process checks and ensure timely completion of batches.
  • Ensure line clearance before starting operations.

2. Compliance & Documentation

  • Ensure compliance with cGMP, WHO, USFDA, EU, MHRA, and other regulatory standards.
  • Review and approve BMR, BPR, and related production documentation.
  • Participate in internal and external audits (regulatory and customer).
  • Initiate and handle deviations, CAPA, and change controls effectively.

3. Manpower & Training

  • Supervise and train production executives, officers, and operators.
  • Plan manpower deployment and shift scheduling.
  • Conduct on-the-job and periodic GMP training programs for team members.

4. Equipment & Process Management

  • Ensure proper operation, cleaning, and maintenance of manufacturing and sterilization equipment (Autoclaves, Filling Machines, LAFs, Compounding vessels, etc.).
  • Coordinate with the Engineering department for preventive and breakdown maintenance.
  • Participate in equipment qualification and process validation activities.

5. Process Improvement & Efficiency

  • Identify areas for productivity improvement and cost reduction.
  • Support technology transfer, scale-up, and new product introduction.
  • Drive continuous improvement initiatives like 5S, Kaizen, and Lean Manufacturing.

Skills

USFDASterileFillingLyophilizationVial WashingProductionWashingManagementBatch ManufacturingOperationsLean ManufacturingMaintenanceManufacturing OperationsProduction OperationsProduction

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