ROBIN SUN

· Purifying sample media by operating Stainless-Steel and Disposable Bioreactors and understanding their mechanism and controls.

· Troubleshooting the mechanism and working of bioreactors with sample media (water).

· Performed Ultrafiltration and Diafiltration on provided media for purification.

· Column Packing with a thorough understanding of the machinery.

• Reviewing Batch Packaging records, Certificates of Analysis (CoA) & Certificates of Conformance (CoC)
• Raising Batch Packaging Records and label printing for production
• Initiating Deviations, Corrective Action Requests, and implementing CAPA as required, and in a timely manner
• Involving in supplier non-conformance and complaint activities
• Ensuring issues are effectively communicated and escalated to the QC/QA Manager/designee
• Perform AQLs, Stop Signs, Gemba walks and quality inspections such as equipment LUMAC logs
• Ensure compliance with cGMP, GMP and GDP requirements, and SOPs, in all activities to ensure product safety and quality
• Computer Proficiency: Excellent Microsoft, MasterControl, JDE, and Antares Software Skills
• Archive batch documents samples and update the PQR database after QP release
• CDMO working experience and coordination with multiple departments; Planning, Production and Quality Systems.

• Inspecting incoming receipt and goods delivered into the warehouse
• Material labeling activities and reviewing of physical inventory reports
• Preparing PUQ certificates for Pack Under Quarantine batches
• Participating in production meetings for continuous evaluation and improvement initiatives to adhere to quality and cGMP
• Collaborating internally with QA Operations, Warehouse, Production and Planning
• Monitoring of shipment & disposal operations and room release for sampling and dispensing operations
• Participating in warehouse tours during internal and external audits
• Perform all duties in accordance with GMP requirements, SOPs, and controlled documents.