Assistant Manager-FIA

Sd Biosensor Healthcare

8 - 13 years

6 - 14 Lacs

manesar

Posted:3 days ago| Platform:

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Skills Required

fluorescence rapid immuno uncut sheet

Work Mode

Work from Office

Job Type

Full Time

Job Description

Department:

Job Responsibilities

Oversee
end-to-end production
of
FIA reagents, buffers, calibrators, controls, and kits
.
Ensure production as per
BMR/BPR, SOPs, STPs, and validated processes
.
Monitor
daily production planning
, achieve targets, and ensure manpower allocation.
Coordinate with
PPC, QC, QA, Store, and R&D
for smooth production activities.
Ensure accuracy in
weighing, mixing, reagent preparation, dispensing, filling, sealing, and labeling
.
Implement and monitor
Good Manufacturing Practices (GMP)
and
ISO 13485
compliance in production areas.
Ensure
equipment calibration, maintenance, and qualification
for FIA manufacturing lines.
Review and verify
batch records, logbooks, and production reports
.
Handle
deviations, change controls, CAPA
, and participate in investigations.
Support
process optimization, yield improvement, cost reduction
, and workflow efficiency.
Train and supervise production operators and technicians for FIA kits.
Ensure
material availability
by coordinating with SCM/PPC for RM & PM.
Participate in
internal and external audits
for regulatory compliance.
Ensure strict adherence to
EHS, hygiene, contamination control
, and 5S in production areas.
Maintain
real-time production MIS
, consumption records, and inventory accountability.

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