Startup < 100
Quality / Clinical study / Clinical development /
– Sterile GMP auditor (Pharmaceutical industry)
– Specialized : GMP part 1, Current Annex 1, LD13
– French speaking
– Knowledge about sterilizing filtration
– Knowledge on clinical studies phase 2 (investigational drug product) would be appreciated
– We are looking for an auditor (specialized in production of sterile drugs) to carry out an audit at one of our subcontractors.
– The production site is located in France. We are aiming to qualify this site for the production of an experimental drug which will be used for a clinical trials phase 2.
– Our project include : Audit preparation, create the agenda for the audit according to the expected scope, 2 days audit on site , Audit report writing, Review of the CAPA plan
– Current audit date proposition from the production site : 12th & 13th of December 2023
Experience 5 – 10 years,Experience > 10 years
FTE / nb of days per week
Limoges , France
Any other information of interest