Materials Management
Manage biopharmaceuticals materials and materials flow according to established procedures for meeting batch requirements
Type
Functional
Competency Area
Production
Levels
Apply materials management procedures to safely handle, prepare, and dispense materials
Identify safety hazards and apply adequate risk controls for handling raw materials
Process documents on receiving and delivering of materials in batches according to organisational practices
Load, transport and unload materials following safe methods and organisational procedures
Sample raw materials and send for quality inspections
Handle batch materials in cleanrooms
Carry out batch and materials dispensing operations according to organisational procedures, reporting specifications and any abnormalities to authorised personnel
Record dispensed materials in batches according to CGMPs
Dispose materials according to established procedures
Implement materials management procedures to transport, prepare and dispense materials
Implement materials flow procedures
Implement safety hazard and risk control procedures for handling biopharmaceuticals materials
Develop materials flow schedules and storage capacity plans
Develop batch and materials dispensing procedures
Monitor compliance with materials management procedures
Implement inventory management systems
Manage inventory levels, ensuring availability of raw materials needed for production lines
Identify issues and concerns in materials issues and receipts
Communicate criteria and guidelines for raw materials inspections
Verify that degraded or contaminated materials are disposed of safely and in accordance with appropriate procedures
Inspect materials management plans and provide expertise on optimum methods
Develop materials management procedures
Provide technical expertise on handling requirements for all types of materials in biopharmaceuticals manufacturing facilities
Advise on optimal time norms, conditions and locations for storage of raw materials given the intended end products
Provide recommendations on materials compatibility
Define the critical testing parameters and criteria for materials inspections
Coach others on industry best practices and environmental standards in disposal of degraded or contaminated materials
Establish guidelines on recovery and reprocessing of materials
Set up manufacturing bills of materials
Recommend new equipment and technology transfer to support new materials
handling processes
Develop plans, schedules and controls to manage flow of materials
Review materials identification, handling and disposal procedures
Determine appropriate inventory systems for materials management
Ensure alignment of materials management plans with international regulations relating to
the safe handling of hazardous materials in biopharmaceuticals manufacturing
Review materials management procedures and identify improvements
Develop training curriculum for materials management
Oversee compliance with materials transfer procedures and policies