- We are looking for an experienced Sr. QA Officer for our Headquarters , The Netherlands.
- As a senior QA/QC officer you will support in all GMP aspects related to production and testing of biological 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).
In the interviews it will be clear that:
- You are enthusiastic and comfortable in a dynamic environment.
- You are able to think analytical, innovative and pragmatic.
- You can work both in a team and individually.
- You communicate clearly at all levels;
- you can get your thoughts, ideas and knowledge across in a helpful and clear way.
- Your planning and organization skills allow you to have an overview of the necessary work and you are able to meet deadlines.