About 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 750 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 site based in Oss, we are looking for a
Quality Assurance Officer (Qualification and Validation)
YOUR ROLE
As Quality Assurance Officer, you work within the Quality Management System and are responsible for reviewing and approving equipment qualification and facility documentation, including IQ, OQ and PQ. You help ensure compliance with GMP requirements and support keeping equipment in a qualified state throughout its lifecycle. In addition, you provide QA oversight on supplier qualification, incoming material release and the issuance and control of logbooks.
KEY RESPONSIBILITIES
Qualification and maintenance oversight
Primary responsibility for the review and approval of qualification documentation (IQ, OQ, PQ) for analytical and process equipment, facilities, and utilities.
Provide QA oversight of maintenance activities related to GMP equipment in close collaboration with the C&Q department.
Experience in cleanroom environments, including qualification activities, is considered an advantage.
Materials and release activities
Review and approve the release of incoming materials for GMP use.
Supplier and service provider management
Maintain the qualification status of material suppliers and service providers.
Review and approve supplier qualification documentation in line with QMS requirements.
QA oversight and inspections
Perform internal QA inspections and walk-through audits.
Documentation and QMS
Support deviations, investigations, CAPAs and change controls related to process equipment, facilities and utilities.
Participate in document management processes.
Write, review and approve procedures, instructions and related GMP documentation.
Maintain and monitor the QA inbox (analyse quality-related issues and ensure appropriate follow-up actions).
Adhere to and actively promote the Quality Management System.
Ensure proper issuance, control and management of logbooks.
YOUR PROFILE
- You have a bachelor degree in pharmaceutical sciences, chemistry or a related field. Candidates with a relevant secondary vocational education (Dutch MBO) background and strong experience will also be considered.
- You have at least 3 years of relevant experience in the pharmaceutical industry.
- You have experience with and good knowledge of quality management systems such as cGMP and ISPE guidelines.
- You feel comfortable in a dynamic and changing environment.
- You like to learn and develop yourself continuously.
- You are flexible, solution-oriented and a strong team player.
- You have an analytical mindset and are able to work accurately under pressure.
- You have good communication skills and are fluent in Dutch and English, both written and spoken.
- You show initiative and enjoy contributing ideas for improvement.
WHAT WE OFFER
Ardena is a science-driven and people-focused employer. Working at Ardena means contributing to pharmaceutical projects that support the availability, safety, and quality of medicines for patients worldwide.
Ardena offers an international working environment where employees are encouraged to develop their expertise, take ownership, and grow their careers across functions and locations.
Benefits and perks at Ardena include:
- International and collaborative work environment across European and US sites
- Access to professional development and training programs
- Meaningful work on pharmaceutical development projects that advance patient health
- A values-driven culture guided by Ardena’s CARE principles: Communicative, Accountable, Reliable, and Excellent
Ready to apply? Please click on the application button.
