Functieomschrijving (Sr) QA/QC officer GMP
As a senior QA/QC officer you will support in all GMP aspects related to production and testing of biologicals for clinical trials. Additionally, you will lead process improvement projects within QC and QA (e.g. sample management, risk management, change management). The activities will include, but are not limited to, monitoring of the GMP system throughout the manufacturing process, investigating and troubleshooting any potential issues that arise, reviewing and advising on assay validation protocols/reports, advising on the content of process related documentation (such as bill of testing, master batch records, etc.), assessing changes, reviewing and/or performing root cause analysis, defining and implementing preventive/corrective actions, and providing support during customer audits. Additionally, you will be the first QA/QC point of contact for any GMP related questions.
You will join a stimulating group of international researchers in a very collaborative environment. This position reports to the Director Quality Assurance.
- Bachelor or master degree in life science, biotechnology, biochemical engineering or related subject;
- At least five years’ experience at QA/QC in biotechnology or biopharmaceutical industry, preferably in production of early clinical trial material;
- Experience with and understanding of GMP regulations;
- Good command of the English and Dutch language (written and spoken).
My client focuses on accelerating the transition of biopharmaceutical product candidates from discovery to the clinic with improved success and lower cost.
Hereto, they have developed a portfolio of technologies aimed to improve product yield , reduce process development time and increase product stability. These technologies have amply demonstrated to improve speed and reduce cost in biopharmaceutical development, accelerating the journey from bench to clinic.
With its 75 haighly educated staff the company, with laboratories in USA and the Netherlands, is well positioned to take on any challenge associated with the development of complex biological medicines be it proteins, antibodies, vaccines or viral vectors.