Quality Assurance Officer

3 maanden geleden

Assen, Nederland Ardena Voltijd

**About us**

**Ardena** is a leading contract research organization serving the pharmaceutical industry. We support pharmaceutical companies—from biotech startups to large pharmaceutical corporations—in bringing new drugs to the clinic and the market. We offer a comprehensive and integrated portfolio of services for drug development, manufacturing, and bioanalysis.

Ardena is a rapidly growing, internationally oriented organization with a dedicated team of over 500 professionals operating across five locations in Belgium, the Netherlands, Sweden, and Spain. We pride ourselves on fostering an open and transparent culture, where team spirit, an open mindset, and ownership are core values.

Our laboratory in Assen is a highly specialized and innovative facility that offers a wide range of bioanalytical services to the global pharmaceutical industry, from drug discovery research through to Phase IV clinical studies. In our recently expanded and renovated GLP-compliant laboratory, our mission is to provide quantitative and qualitative analyses of all types of drugs, as well as biomarkers in biological matrices, using techniques such as LC-MS/MS, ligand-binding assays (ELISA), qPCR, and flow cytometry.

Our enthusiastic team of approximately 100 bioanalytical scientists brings expertise across a diverse range of areas, from small molecules and peptides to cells and proteins, including antibodies and antibody-drug conjugates, oligonucleotides, vaccines, and nanoparticles.

For the Ardena Bioanalysis Business Unit based in Assen, The Netherlands, we are looking for a

**Qality Assurance Officer**

**Your key responsibilities**
- Planning, conduct and reporting of study-, process-, facility
- and supplier qualification audits
- Monitoring and follow-up on audit finding responses
- Facilitating regulatory inspections and sponsor audits
- Involvement in quality improvement projects and activities
- Maintenance of the quality management system Training and guidance on GLP requirements and best practices

**Your profile looks like**
- A thorough understanding of and experience with GLP quality management concepts and principles, 21CFRp11 regulation and GAMP guidelines
- Takes initiative and has a persistent and pro-active can-do attitude
- Strong networker with good negotiation, problem solving and analytical skills
- Accurate, proactive, critical, decisive, and flexible
- Works well with others (Team Player), including internal teams and external stakeholders
- Bachelor's degree or equivalent experience

**What we offer**
- Salary range: € 3000;
- to € 4500;
- gross per month (based on a 40-hour workweek)
- A true learning environment where you will have the ability to grow your skills
- A dynamic working environment with friendly and enthusiastic colleagues
- A company culture with open communication, where employee well-being is highly valued
- An attractive remuneration package Flexible working hours

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