Assistant Manager

• Bulk Drug, API Production.
• SOPs, cGMP, Reactor, BMR Review, Raw Material
• Hydrogenation, batch production
• Key member of troubleshooting the production of an FDA license product
• In process checking on various intermediate steps
• Developing new production methods or improving existing ones to increase efficiency or quality of product
• maintenance and repairs of equipment used in production processes
• Active calculation batch reconciliation on various stages
• To be responsible for Batch start up activity, monitoring, calibration of balance and other instruction given by the Superior.
• To review technical documents like batch records, cleaning records, validation protocols, cleaning verification protocols.
• To be responsible for receiving raw materials to delivering the finished products.
• Conducting chemical analyses of new products to ensure that they meet safety standards
• Preparing and review of various document regarding manufacturing like SOP, Batch production records, Reconciliation record
• Preparation of daily production report
• Prepare safety manuals for operator, Provide training to operator for plant operation
• Monitoring of Preventive maintenance schedule and planning.

Bulk Drug, API Production- High Potency Experience (Oncology)

• Isolator Handling
• Isolator cleaning
• Packing Oncology Product
• Documentation of Oncology Product
• SOPs, cGMP, Reactor, BMR Review, Raw Material
• Hydrogenation, batch production
• Key member of troubleshooting the production of an FDA license product
• In process checking on various intermediate steps
• Developing new production methods or improving existing ones to increase efficiency or quality of product