Description
A global pharmaceutical organisation based in Austria requires a Consultant who will work within their validation department in the start up project for the new filling line for prefilled syringes.Requested Skills:
* Microbiologist
* Long term experience in pharmaceutical industry in sterile sites
* Experience in start up of production lines (preferably liquid syringe filling): e.g. gridmapping for microbiological environmental monitoring, qualification of utilities (nitrogen, cleansteam, water, compressed air),qualification of autoclaves, material chambers, setting up of personnel and material workflow, smokestudies, qualification of washing equipment etc.
* Experience in microbiological laboratory testing methods needed for start up:
e.g. Bioindicator testing, CCIT testing, Bioburden testing etc.
* Experience in aseptic working techniques for cleanrooms
* Experience in Media fills for sterile production lines
* Experience in Training of cleanroom personnel
* Language - English and German spoken and written
* Capability of writing risk assessments, SOPs, concept papers
* Capability for team work
* Self-organised, result driven, focused
This a contract opportunity starting as soon as possible. We are offering competitive rates of pay, please apply now for more information!