Materials Management

Manage biopharmaceuticals materials and materials flow according to established procedures for meeting batch requirements



Competency Area



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