MSAT Process Expert

5 days ago


Cambridge, Cambridgeshire, United Kingdom Adepto Technical Recruitment Ltd Full time

We are looking for a highly skilled GMP Manufacturing Professional to join our team. This is a permanent role with a competitive salary of $120,000 per annum, plus benefits such as Personal Days, Private Medical Cover, Enhanced MAT/PAT Leave, and Bonus.

The ideal candidate will have experience in drafting, writing, and reviewing process descriptions, equipment SOPs, process change controls, process risk assessments, batch manufacturing records, and other documentation relevant to GMP manufacturing. They will also be able to collaborate with the team to improve and/or troubleshoot manufacturing processes and propose needed protocols for data collections and/or experimentation.

Responsibilities:
  • Drafting, writing, and reviewing Technology Transfer documentation for any processes being used for fill-finish.
  • Collaboratively improving and/or troubleshooting manufacturing processes and proposing needed protocols for data collections and/or experimentation.
  • Being the technical author of deviation impact assessments which feed into the Quality Management System.
  • Conducting risk analysis of processes including prioritisation and implementation of mitigations.


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