Executive / Senior Executive Upstream Production - Vizag

Role & responsibilities

Responsible for Operate of process designated equipment, monitor & maintain smooth process flow in the plant during the assigned shift. This includes overseeing the fermentation operations, ensuring compliance with cGMP and safety standards and ensuring smooth execution of the batch as per the production schedule and approved procedures

Shift Operations Management

• Supervise and coordinate all upstream (USP) production activities during the shift including media preparation, Inoculation, sterilization, Batch monitoring and harvest.
• Ensure adherence to batch manufacturing records (BMR), SOPs, and GMP guidelines.
• Monitor and record all process parameters (pH, DO, temperature, agitation speed, etc.) and ensure deviations are promptly reported and documented.
• Review shift logbooks and ensure proper handover between shifts.

2. Team Leadership & Training

• Lead, guide, and supervise operators, executives, and technicians in the USP area.
• Allocate manpower and ensure optimal utilization of resources during the shift.
• Train team members on cGMP, aseptic techniques, and safe handling of equipment and materials.

3. Equipment & Process Management

• Ensure availability, cleanliness, and readiness of all USP equipment (bioreactors, autoclaves, Media vessels, etc.).
• Oversee CIP (Clean-In-Place) and SIP (Sterilize-In-Place) operations.
• Coordinate with Engineering for preventive maintenance, calibration, and troubleshooting of equipment.
• Verify line clearance before initiating batch operations.
• Support internal and external audits and provide necessary process documentation

4. Compliance & Documentation

• Ensure that all operations comply with cGMP, EHS, and company policies.
• Review batch records, logbooks, and cleaning records for completeness and accuracy.
• Report deviations, non-conformances, and ensure timely initiation of CAPA.
• Participate in internal and external audits as a process representative.

5. Coordination & Communication

• Collaborate with QA, QC, Downstream Processing (DSP), and Warehouse teams for smooth batch execution.
• Communicate critical issues, process alarms, or safety incidents to the Production Manager immediately.
• Participate in daily production meetings and contribute to process improvements.