Oxford Global Resources is looking for a SME Lead, specialized in aseptic fill-finish for a very important project based in Barcelna (Spain) 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.