Currently our client is looking for a Manufacturing Specialist. In this role you are documenting product and process impact assessments as part of material management project. The resulting documents are upon finalization used as source documents for regulatory filings and/or supportive documents to justification in controlled changes.
The Manufacturing Specialist can also have a role in qualification of new raw materials. For this task materials need to be assessed according the regulatory criteria for excipients and where possible information need to be collected from manufacturers or suppliers of the materials.
· New supplier Product impact assessment based on new excipient attributes;
· New supplier Process impact assessment based on new excipient attributes;
· Material stability impact assessment based on stability studies, assessments and other available information