Associate QA production in Breda fulltime
Amgen is an international biotechnology company that makes an active contribution to better care. Amgen scientists have been developing innovative therapies for patients with serious illnesses since 1980. Their product portfolio encompasses the following therapeutic areas: oncology, kidney diseases, hematology, bone diseases and cardiovascular diseases. At the Breda site, Amgen medicines are labeled, provided with patient information leaflets, packaged and distributed throughout Europe and to a growing number of countries in other parts of the world. It is responsible for the availability of their medicines and clinical trials in the Netherlands.
Perform finished product checks during (commercial) production runs
Compile and review batch records for lots assembled, packaged and labeled at ABR and contract manufacturers in preparation for disposition by QP.
Act as author for operational SOP’s and Work Instructions
Review of operational SOP’s and Work Instructions
Review and approve deviation records
This is a 3 shift job. Early shift: 06.30 – 15.00 Late shift: 14.30 – 23.00 Night shift: 22.30 – 07.00
MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience.
Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
Manufacturing and/or Quality analytical processes and operations.
Fluent in English language.
You will start with a year contract via Herakles.
More information about the Senior Associate QA fulltime? Please contact the recruiter on the right hand side.