Production Shift Incharge
2 weeks ago
Job Summary:
The Production Shift In-Charge USP is responsible for leading and supervising all upstream production activities during the assigned shift. This includes overseeing Microbial / mammalian operations, ensuring compliance with cGMP and safety standards, managing manpower, and ensuring smooth execution of the batch as per the production schedule and approved procedures.
Role & responsibilities
1. Shift Operations Management
- Supervise and coordinate all upstream (USP) production activities during the shift, including media preparation, seed train, bioreactor operations, 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, incubators, fermenters, 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.
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.
Preferred candidate profile
Key Competencies:
- Leadership and team management skills.
- Strong problem-solving and decision-making ability.
- Excellent communication and documentation skills.
- Attention to detail and commitment to compliance.
- Ability to work in rotating shifts and under pressure.
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