Deviation and Investigation Management:

• Open deviations within required timeframes
• Author investigations
• Owning investigations and developing corrective actions
• Use process knowledge and root cause investigation tools to identify root causes of product and process deviations.
• Ensures robustness (complete, accurate and defendable) of all critical and major investigations
• Author and execute any experiments or runs to support investigations
• Work cross-functionally to assess and analyze deviations and investigations to determine impact
• Work cross-functionally to ensure production continues in a compliant manner in the event of a deviation and document accordingly.

Corrective and Preventative Actions:

• Generation and documentation of effective corrective and preventative actions
• Ensures all CAPAs are implemented through GMP systems (e.g. MBR revision, training, etc.)
• Monitor and ensure effectiveness checks of CAPAs are conducted
• Communicate to the production team any training or awareness events to reinforce quality behaviours.
• MES Order Management:
• Generation of manufacturing orders within the MES system, as required. 
• Training:
• Develop training (as immediate response to unexpected events, for technical document execution, and new products/processes) to the Cell Processing team, as required.
• Maintain compliance with training requirement