Key Responsibilities
Shift & Production Schedule Adherence
- Follow assigned shift schedules and execute production tasks according to the process requirements and production plan.
Plasma Handling & Processing
- Handle plasma collection, sanitization, washing, cutting, pooling, thawing, and fractionation process steps.
GMP Compliance & Documentation
- Ensure compliance with all GMP practices and approved procedures. Accurately document activities in BMRs, logbooks, and record sheets.
Sampling & QC Coordination
- Collect and send in-process samples to Quality Control for required analysis as per standard procedures.
Equipment Cleaning & Sterilization
- Perform COP (Cleaning Out of Place), CIP (Cleaning In Place), PHT (Pre-Heat Treatment), and SIP (Sterilization In Place) of process vessels and equipment.
Calibration Activities
- Calibrate equipment such as pH meters, conductivity meters, turbidity meters, weighing balances, etc., as per defined schedules.
Buffer & Solution Preparation
- Prepare buffers and process solutions as required for plasma fractionation.
Environmental Monitoring
- Monitor area cleaning, equipment sanitization, differential pressure, temperature, and humidity in designated zones.
Cold Storage Monitoring
- Record and monitor the temperature of freezer rooms and cold rooms to ensure product quality and compliance.
Inventory & Material Readiness
- Check the availability of stock including chemicals, solvents, and raw materials required for manufacturing.
Troubleshooting & Operations Support
- Support daily operations through proactive troubleshooting and management of equipment and processes.
Safety & Incident Reporting
- Follow all safety procedures, ensure proper usage of PPE, and report unsafe conditions or incidents to the shift in-charge.
