Executive / Senior Executive - Production Downstream - Vizag

Role & responsibilities

Responsible for downstream processing operations during the assigned shift to ensure consistent, efficient, 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 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.

2. 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.

3. 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.

4. Documentation & Compliance

• Review and verify batch records, logbooks, and cleaning records for accuracy and completeness.
• Ensure compliance with cGMP, GDP (Good Documentation Practices), EHS (Environment, 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.

5. 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.