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.
Deputy General Manager • India