solution preparation, filtration, filling, sealing, sterilization (autoclave), and visual inspection
.
Ensure all activities are carried out as per
approved Batch Manufacturing Records (BMRs)
, SOPs, and production schedules.
Perform and monitor
aseptic operations
in
classified cleanroom areas (Grade A/B/C/D)
.
Ensure compliance with
cGMP, cGLP, GDP
, and
data integrity
requirements.
Carry out and verify
line clearance, equipment cleaning, CIP/SIP
, and changeover activities.
Monitor
critical process parameters (CPPs)
and ensure adherence to validated manufacturing processes.
Ensure proper operation and routine checks of
LVP equipment
, including:
Compounding vessels
Filtration systems
Filling and sealing machines
Autoclaves / Terminal sterilizers
Maintain accurate and contemporaneous
production documentation
, including BMRs, equipment logbooks, and cleaning records.
Identify, report, and support investigations of
deviations, OOS/OOT trends (production-related), and incidents
.
Participate in
change control, CAPA implementation
, and continuous improvement activities.
Coordinate with
Quality Assurance, Quality Control, Engineering, and Microbiology
for smooth operations.
Ensure strict adherence to
EHS, gowning, and aseptic behavior
within production areas.
Support
internal, customer, and regulatory audits/inspections
(WHO-GMP, USFDA, EU-GMP, etc.).
Key Skills & Competencies:
Hands-on experience in
Injectable / LVP manufacturing
Strong knowledge of
aseptic processing and cleanroom operations
Understanding of
sterilization principles, filtration, and contamination control
Familiarity with
validation, qualification, and regulatory expectations
for sterile products
Good documentation, communication, and team-coordination skills
Willingness to work in
shift operations
, if required
Job Types: Full-time, Permanent
Pay: ₹25,000.00 - ₹45,000.00 per month
Benefits:
Health insurance
Paid time off
Provident Fund
Work Location: In person
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