Description
The Plasma Products division processes the plasma into medicines for coagulation and immune disorders. Our client is a major supplier of medicines for patients in the Netherlands. A variety of isolation techniques produces coagulation factors, protease inhibitors, immunoglobulins and albumin. Plasma Products works closely with sister organisations in other countries, such as the Department for Central Fractioning (CAF) in Belgium and the Finnish Red Cross.Projects Ongoing:
• Upscaling of an existing process
• New Product Introduction / Existing Product Transfers
• New Production Building – concept phase
Upscaling of an existing process – project info:
In order to meet the demand and high profile project they require to build a clean room Class D and qualify this as well as the clean utilities & process equipment. Clean room requires to be constructed.
Process equipment: chromatography column, filter units, thawing baths, mobile tanks (cleaning validation needs to happen), vessels
Clean utilities: Purified Water (PW), Clean Air, Clean In Place (CIP)
The successful individual must be proactive and will be required to complete:
• Qualification IQ OQ PQ
• Write Documentation in English + Review Protocols