Location: United Kingdom
Duration: 2 day Audit and then report writing (1 week long)
Start Date: Mid April
Job Description: Originally our client was planning on having their Phase 1 and 2 trials in the US but now have decided to shift to the EU due to a sourcing issue of the material they need for their product. Doxorubicin is the material needed and they have landed on a testing facility in the UK that can test Doxorubicin that has been aerosolized. Client needs an experienced auditor well versed in Combination Product regulations, especially those for for the EU (specific EMA Annexes for Combination Products to be familiar with), but CFR 211 for FDA. Need to provide the audit report and state that this facility would adhere to US and EU GMPs so that they can get their IMPD approved at the end of May. Auditor will look at the lab procedures for handling aerosol samples as well as assessment of overall QMS that they have to make sure that they are in compliance and that the Doxorubicin is Aerosolized in the proper size and distribution.
Skills: Audit/Auditing, Combination Product
Education: Experience outweighs Degree
First choice is someone local to the UK area, 2nd choice is someone regional and able to go onsite for the 2 day audit, 3rd choice is a US citizen.