Deputy General Manager (DGM) / Assistant General Manager (AGM) – Downstream Production (API)

Key Responsibilities:

Operational Leadership:

• Lead and oversee all downstream API production activities including

  filtration, centrifugation, drying, milling, sifting, and packing

  .
• Ensure adherence to

  production targets

  ,

  quality standards

  , and

  delivery timelines

  .
• Drive continuous improvement in

  yield, throughput, and efficiency

  while minimizing waste and downtime.

Compliance & Documentation:

• Ensure

  cGMP

  ,

  FDA

  ,

  WHO

  , and other regulatory compliance in downstream operations.
• Review and approve

  Batch Manufacturing Records (BMRs)

  ,

  SOPs

  , and

  Change Controls

  related to downstream processes.
• Lead and support

  regulatory audits (USFDA, EU, TGA, etc.)

  and internal quality inspections.

Team Management:

• Manage and mentor a team of

  shift managers, supervisors, operators

  , and technical staff.
• Conduct

  performance reviews

  ,

  skill development

  , and ensure a culture of

  safety and accountability

  .

Process Improvement & Technology:

• Collaborate with Process Engineering, R&D, and QA to implement

  process optimizations

  and

  technology upgrades

  .
• Drive initiatives such as

  QbD, PAT

  , and

  Lean Manufacturing

  in downstream operations.

Inventory & Cost Control:

• Coordinate with SCM to ensure availability of

  consumables and utilities

  for uninterrupted operations.
• Monitor and control

  production costs

  ,

  material losses

  , and

  energy consumption

  .

Experience Required:

15+ Years in API Manufacturing.