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Subject Matter Expert (Fill and Finish process)

  • Location:

    Rome, Italy

  • Contact:

    Fernando Martin

  • Job type:


  • Industry:


  • Contact email:

Oxford Global Resources is looking for a SME Lead, specialized in aseptic fill-finish for a very important project based in Italy for a multinational pharmaceutical company.

The description of the main responsibilities and requirements for this role are:

Hands on experience with aseptic fill-finish, using isolator technology and RABS technology.

  • Hands on experience with filling line qualification and start up - smoke studies, media fills (interventions), filling accuracy, etc...
  • Experience with disposable systems both for filling line (peristaltic pump) as well as for buffer prep and compounding.
  • Experience with operation and qualification of cleaning and sanitizing - fumigation/VHP - systems.
  • Experience with EMA and FDA guidelines specifically for compounding / fill finish.
  • Can lead improvement programs and train on-site operational teams to meet EMA / FDA requirements.
  • Experience with leading (first line) investigations, excellent documentation and reporting skills.
  • Able to support, write/review regulatory filing.
  • Coordinate with TLI / Technical Operations platform and planning team to ensure project alignment.

If you are interesting in this project, don't hesitate and apply attaching your CV.