Introduction to Ardena
Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) specializing in precision medicine development. Ardena supports pharmaceutical and biotechnology companies in bringing innovative, complex molecules from discovery to market.
The Ardena Group operates from five sites across Europe and the United States, employing more than 700 professionals. Ardena European sites are located in Oss and Assen (the Netherlands), Ghent (Belgium), and Pamplona (Spain). Ardena US facility is based in Somerset, New Jersey.
For the Ardena Corporate IT department we are looking for a
Quality Assurance Computerized Systems Validation (QA CSV) Specialist
We are looking for a skilled and motivated professional eager to further their careers in an exciting and fast-paced environment.
WHAT YOU WILL WORK ON
Within our fast-growing environment, we are continuously striving for an optimal level of processes and automation. In this specific role, you will be responsible for providing QA oversight of corporate GxP computerized systems.
YOUR KEY RESPONSIBILITIES
You contribute to strengthening the Quality posture of Ardena’s Corporate IT department, from both a technical and procedural perspective.
Interpret relevant rules and regulations for both EU and US compliance, including remaining up to date with them.
You will draw up and champion validation deliverables, e.g. project plans and validation documents according to international GxP standards.
You take part in setting up and documenting a risk-based validation strategy.
You draft and review procedures.
You are jointly responsible for determining the impact of changes.
You will be performing critical reviews of deviations and CAPA.
You will closely work together with colleagues from the QA departments, the IT department, validation engineers and others across different departments depending on the project.
YOUR PROFILE LOOKS LIKE/ RESEMBLES
Bachelor’s degree in a scientific direction (Chemistry, Chemical Engineering, Biotechnology, Pharmacy, IT)
At least 5 years’ QA and GxP validation experience in the pharmaceutical industry
Advise and solve validation problems related to projects, process development, risk mitigation, etc.
Project management experience is beneficial
Comfortable in a dynamic and changing environment
Eagerness to learn and develop yourself
Flexible, a problem solver and a team player
Accurate and an analytical mindset
Interest in AI
Excellent communication skills English (written as well as spoken)
Dutch and Spanish are beneficial
Willing and able to travel to several locations to support and work with the local teams. (Travel 20% of the time)
WHAT WE OFFER
✔ A competitive salary
✔ Flexible working hours
✔ Hybrid working
✔ A dynamic, international work environment with career growth opportunities
✔ Access to Ardena Academy, our internal learning platform for professional development
✔ A chance to contribute to groundbreaking drug development projects that make a real impact
HOW TO APPLY
Ready to start your career path with Ardena? Click the application button and join us in shaping the future of drug development!
Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union) will not be given a status update. Agency calls will not be appreciated.
We are a global provider of drug development and discovery services, encompassing drug substance, drug product, bioanalysis, and CMC regulatory services across small molecules, large molecules, and nanomedicines. Our six international locations offer comprehensive CDMO and BioAnalytical CRO services to a wide range of clients worldwide.
We recognize the intricate challenges associated with advancing a promising molecule from the laboratory to the patient. Our multidisciplinary team is eager to collaborate with you throughout your development process, utilizing specialized technologies to optimize formulation and manufacturing. We possess extensive expertise in spray drying, hot melt extrusion, and lipid-based formulations that enhance bioavailability and solubility. Additionally, our capabilities include polymeric, metal, and lipid nanoparticles for advanced drug delivery applications, as well as high-potency and controlled substance handling for highly specialized therapeutics.
At Ardena, all work adheres to the appropriate regulatory standards as you progress through the clinical development pathway. Please contact us to further discuss your clinical and scientific objectives and explore how we can work together.
