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.