10 Sep
|
Laurus Bio
|
Visakhapatnam
10 Sep
Laurus Bio
Visakhapatnam
Manufacturing - DSP/USP
Location - Vizag
Exp - 2 - 5 years
Education - BSc. / MSc.
Salary 3 - 5 LPA
Role & responsibilities
Responsible for downstream/ upstream processing operations during the assigned shift to ensure consistent, effective, and GMP-compliant production of biological products (e.g., monoclonal antibodies, vaccines, recombinant proteins). The role involves supervising the purification process, ensuring equipment readiness, and maintaining quality and safety standards.
Shift Operations Management
Supervise all downstream/ upstream production activities, including harvest, filtration, chromatography, ultrafiltration/diafiltration (UF/DF) and lyophilization.
Ensure batch manufacturing records (BMRs) are followed strictly as per approved procedures and cGMP guidelines.
Monitor process parameters (flow rates, pressures, conductivity, pH, temperature, etc.) and record data accurately.
Adhering to cGMP, GDP and safety regulations, FSSAI / ISO / etc. standards in the plant
Perform in-process checks and ensure timely sampling and coordination with the QC team.
Oversee batch changeovers and line clearances between operations.
Team Leadership & Training
Lead, train, and supervise production executives, operators, and contract staff during the shift.
Allocate manpower effectively to ensure smooth workflow and timely batch execution.
Conduct on-the-job training for team members on GMP, safety, and equipment operation.
Equipment & Process Management
Ensure readiness, cleaning, and sterilization of all DSP equipment (e.g., chromatography, TFF systems, centrifuges, filtration units and lyophilizer.
Coordinate with Engineering for equipment maintenance, calibration, and troubleshooting.
Review equipment logs and ensure timely updates in line with GMP compliance.
Documentation & Compliance
Review and verify batch records, logbooks, and cleaning records for accuracy and completeness.
Ensure compliance with cGMP, GDP (Positive Documentation Practices), EHS (Workplace, Health & Safety), and company quality standards.
Identify and report deviations, non-conformances, and assist in root cause analysis and CAPA implementation.
Support internal and external audits and provide necessary process documentation.
Coordination & Communication
Collaborate with Upstream (USP), QA, QC, Warehouse, and Engineering teams for coordinated production activities.
Communicate critical process issues, equipment alarms, or safety incidents promptly to the Production Manager.
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