At Radboud Translational Medicine (RTM), we are currently looking for a Qualified Person (QP), with good understanding of both EU cGMP guidelines and Quality Management systems, to join our team!

As QP you are responsible for batch certification (starting around 07.00 a.m.). You ensure that our (investigational) products are produced and checked in accordance with legal requirements, quality guidelines, procedures and the manufacturing authorisation. You will work in close collaboration with other departments (Production, Quality Control, Quality Assurance, dept. of Radiology and Nuclear Medicine of Radboudumc).

Tasks and responsibilities

• Review of batch documentation and manufacturing process to support the decision to release the product in accordance with all licensing and GMP requirements.
• Review and approve deviations, CAPA, Change Control, Complaints and procedures.
• Advise in various research, development and improvement projects and advise on the adequacy of validation of facilities, equipment and new products / processes.
• Provide Quality oversight to the introduction of New Products.
• Supervising and coordinating inspections by external (regulatory) authorities (e.g. IGJ)
• Perform and/or support internal and external audits.
• Support the Head of QA in establishing and maintaining quality management systems.
• Act as member of the management team.
• Maintain current knowledge of pharmaceutical legislation and best practices and implementation thereof.

We are looking for an energetic and social team player with an open and creative outlook. You are able to work under pressure and make good, timely decisions. It is important that you have knowledge of sterile product manufactureing and associated QA requirements, including aseptic preparation. Knowledge of and experience with radiopharmaceuticals is a pre. You are abile to communicate effectively with all levels of personnel. You will promote a culture of continuous improvement.

Furthermore:

• Academic degree in Pharmacy, Chemistry, Pharmaceutical Chemistry & Technology, Biology or equivalent.
• At least 3 years of experience in a GMP regulated environment (QP, QA and/or QC) within a pharmaceutical company.
• Excellent verbal and writing proficiency in English and Dutch.

Working at Radboud university medical center means that you are ahead of the curve and working together on the healthcare of the future. And there is more. Our secondary terms of employment are impressive. These are fully tailored to you thanks to our Employment Conditions Selection Model. At Radboud university medical center, you will be given trust, and you will take the responsibility to handle everything together. We provide annual courses, both professional and personal.

• In addition to your monthly salary and an annual vacation allowance of 8%, you will receive an end-of-year bonus of 8.3%.
• If you work irregular hours, you will receive an allowance.
• As a full-time employee (36 hours per week), you are entitled to approximately 168 vacation hours (over 23 days) per year.
• Radboud university medical center pays 70% of the pension premium. You pay the rest of the premium with your gross salary.
• You get a discount on health insurance as well: you can take advantage of two group health insurance plans. UMC Zorgverzekering and CZ collectief.

In addition to our terms of employment, we also offer employees various other attractive facilities, such as childcare and sports facilities. Want to learn more? Take a look at the CAO UMC.

Radboudumc

RTM is a fully equipped cyclotron facility manufacturing radiopharmaceuticals according to GMP standards. These are intended for use in daily medical practice and biomedical research. We supply our products to both internal and external relations such as hospitals, research institutes and commercial partners.

Our facility

• A Siemens Eclipse HP cyclotron
• Total floor area of 1200 square meters
• Four GMP-qualified production rooms (i.e. clean rooms)
• QC-labs for the testing of radiopharmaceuticals
• Logistic areas for the distribution of radiopharmaceuticals
• A radionuclide lab for preclinical preparations and other research activities

Radboud Translational Medicine is a 100% subsidiary of Radboudumc.

Radboudumc
Radboud university medical center is a university medical center for patient care, scientific research, and education in Nijmegen. Radboud university medical center strives to be at the forefront of shaping the healthcare of the future. We do this in a person-centered and innovative way, and in close collaboration with our network. We want to have a significant impact on healthcare. We want to improve with each passing day, continuously working towards better healthcare, research, and education. And gaining a better understanding of how diseases arise and how we can prevent, treat, and cure them, day in and day out. This way, every patient always receives the best healthcare, now and in the future. Because that is why we do what we do.

Read more about our strategy and what working at Radboud university medical center means. Our colleagues would be happy to tell you about it. #weareradboudumc