Ewan Dunbar

Key Responsibilities include:

• Update and implementation of Electronic Batch Records using the MasterControl system.
• Validation of MasterControl system updates, representing Manufacturing as system SME.
• Execution of qualification for approval of new raw material FBS lot and subsequent validation report writing.
• Implementation of new Batch Document tracking system utilising Monday.com.
• Writing and Investigating Quality Events including implementation of corrective and preventative actions.
• Implementation of Process Improvements through GMP Change Control system.
• Update and Management of GMP Documentation.
• Management and Planning of Production Media and Solution requirements throughout the year.
• Management of operators as room lead to facilitate compliant and effective processing.

Key Responsibilities included:

• Performance of Manufacturing Activities, following instructions in approved production records to facilitate vaccine manufacture in a GMP Cleanroom Envrionment.
• Complying with ALCOA+ principles at all times
• Peer Review of Manufacturing Batch Documentation, Logbooks, Controlled Labels, and QMS.
• Writing and Investigating Quality Events including implementation of corrective and preventative actions.
• Self Management of Training to comply with GMP requirements.