Quality Assurance Manager / Qualified Person
- Develop, roll out and monitor the quality system of our new facility for the production of therapeutic radionuclides.
- As qualified person, take responsibility for certification of production batches.
- Ensure quality in the development of new production processes.
Will you come and help us in our fight against cancer?
With its new NURA programme, SCK CEN significantly increases its contribution to the fight against cancer.
NURA contributes to the development and supply of next-generation radiopharmaceuticals for treating different types of cancer, in cooperation with clinical and industrial partners.
A new facility for the GMP compliant production of Lu-177 radioactive precursor is currently under development.
We are looking for a QA Manager/Qualified Person to support the development, and in a later phase, the operation of this facility.
Your responsibilities include, but are not limited to:
- Evaluate production facility QA/QC needs and capability, identifies gaps, and recommends issue resolution.
- Establish and control quality strategy for the pharmaceutical development of processes to be implemented in production facility.
- Write and develop quality plans and operational quality strategy. Participate in the development of the control strategy.
- Ensure the implementation of the operational quality strategy.
- Monitor the effectiveness of such implementations and makes necessary changes.
- Write or assist in revising procedures and other documents.
- Provide leadership in the interpretation and training of quality initiatives and gains organizational commitment and ownership.
- Make sure that effective systems are used to keep production equipment in a qualified and calibrated state.
- Make sure that deviations are investigated and resolved
- Host and/or support internal audits and inspections (preparation, hosting and post-inspection response coordination and CAPA implementation)
- Perform or support supplier audits.
- As a qualified person, ensure that every batch of product is produced, controlled and documented according to regulations, and be the end-responsible for batch release or rejection.
To join this frontier, you'll need
- Master's degree in industrial pharmacy or pharmaceutical sciences with a legal Qualified Person (QP) accreditation
- Experience in nuclear research and/or a radiopharmacist accreditation is an asset
- Experience in the development and validation of a production process is a significant asset
- Proven experience in the release process and in making decisions in terms of quality
- At least 5 years of experience in a GMP environment
- At least 2 years of experience in quality assurance
- Knowledge of national and international legislation related to GMP
- Passionate with an entrepreneurial spirit
- Willing to work in supervised and controlled areas where radiation protection measures apply
- Excellent communication and management skills to work in a multidisciplinary team in an international environment
- Flexibility, defining priorities and good time management are important