We offer you exciting work as part of a team of experts who treat each other as equals. All over the world. In our biopharmaceutical organization with sites in Germany and the Netherlands we are fast-growing.
At our Amsterdam-based center the focus lies on the GMP-compliant microbial based production of recombinant proteins, vaccines and live microbials as drug substance and drug product.
Your tasks will be :
Writing and review of GMP documents Writing and review of deviations, CAPAs, environmental and utility monitoring system investigations and reports, change controls
Participate in project teams as MF project lead
Execution of internal audits according to audit plan and support during external audits (clients and governmental bodies)
Coordination, maintenance and administration of manufacturing systems.
Training Coordinator Chairman of Tier meetings and environmental and utility monitoring board Meetings
Profound knowledge of Dutch and English language, verbally and written
Minimum of education of HBO level in the orientation of Chemistry, (Micro)Biology or Pharmaceutical Sciences
A minimum of 4 years experience in the pharmaceutical industry
A few years experience as a QA Officer
Excellent verbal and written communication skills
Ability to work with tight deadlines and handle multiple tasks
Computer fluency in MS Office, e.g. Word, Excel, PowerPoint; knowledge of TrackWise is a plus
Experience with FDA compliance is a plus
Exciting work as part of a team of experts who treat each other as equals. All over the world.
Contactpersoon voor deze functie is Diederik van Straalen, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail : diederik xdes.nl Kenmerk : 8604.