Responsible Person (API)

Position

As a QP in training / Responsible Person (API) / Senior QA Specialist, you will play a key role within the PQMS team of NRG PALLAS. You will work closely together with the QA Manager and support the further development, implementation and maintenance of GMP quality systems for radiopharmaceutical API’s, precursors and future medicinal products.

NRG PALLAS is currently transitioning from a development-focused organisation towards future GMP manufacturing. As commercial GMP production has not yet started, the role strongly focuses on supporting product and process development from a GMP perspective and translating development activities into future GMP-compliant manufacturing processes.

A strong focus of this position is building in-depth product and process knowledge. The candidate will work closely together with QC, Innovations and Operations to fully understand the product, analytical methods, process parameters and product-specific risks. The role therefore requires strong scientific understanding and affinity with radiopharmaceutical products and pharmaceutical development.

You will act as one of the main QA contacts for development and innovation projects and help ensure that GMP principles are embedded early in development activities.

As GMP knowledge and pharmaceutical quality systems within the organisation are still developing, we are looking for a candidate who brings strong GMP knowledge, scientific understanding and the ability to independently support and challenge the organisation from a quality perspective.

The position offers a broad and hands-on role with significant responsibility and visibility within the organisation. The candidate is expected to grow into a key QA representative and right hand to the QA Manager.

Main responsibilities

- Support GMP quality assurance activities within product and process development;
- Build detailed product and process knowledge of radiopharmaceutical API’s and precursors;
- Act as QA contact person for Innovations and development projects;
- Work closely together with QC regarding analytical methods, specifications and product understanding;
- Support and review deviations, CAPA’s, change controls and risk assessments;
- Support internal and external audits and inspections;
- Contribute to the development and continuous improvement of the pharmaceutical quality management system;
- Support the transition from development towards future GMP manufacturing;
- Prepare for future Responsible Person (API) and QP responsibilities and product release activities.

Profile

- Master degree in (Radio)pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology or another relevant scientific discipline;
- Preferably a background or strong affinity with radiopharmaceutical products;
- Experience within a GMP-regulated environment, preferably in QA, QC or pharmaceutical R&D;
- Strong scientific interest and ability to build detailed product knowledge;
- Strong communication skills and ability to connect different departments;
- Able to work independently within a dynamic and evolving organisation;
- Pragmatic mindset combined with strong quality awareness;
- Ambition to further develop towards a Responsible Person (API) and/or Qualified Person role is preferred.

Team

You will be joining PQMS, the QA team within the pharmaceutical division of NRG PALLAS.

This team is responsible for establishing, maintaining and continuously improving the GMP quality system for the development and future production of radiopharmaceutical APIs, precursors and medicinal products.

PQMS operates in a dynamic environment where facilities, processes and quality systems are still very much under development, whilst the organisation prepares for GMP production.

The team works closely with Operations, QC, Engineering, Validation and Innovations and plays a central role in translating product and process development into a robust, GMP-compliant production organisation.

Due to the organisation’s growth and the increasing complexity of GMP activities, there is a need for a strong QA professional who can act as a key figure within the team and, as the QA Manager’s right-hand person, help to further professionalise the organisation.

Team

You will be working within our department Fuels & Materials Irradiations (FMI). This department is responsible for the execution of materials and fuels R&D activities on commercial and subsidised basis. The team is responsible for the preparation, execution and follow-up of irradiation projects in and around our nuclear facilities, with a strong focus on safety, reliability and innovation. Within MIT you work closely together with project managers, scientists, experiment designers, engineers and technicians who collectively realize irradiation experiments for materials research, fuel development and other nuclear applications.

The culture within NRG PALLAS and MIT is professional, collegial and informal, with short communication lines and a strong drive to continuously improve. You get a lot of responsibility and autonomy, but you are certainly not on your own: you can build on the knowledge and experience of highly specialized colleagues and on the solid project and safety culture within NRG PALLAS.

Terms of Employment

In addition to a challenging role, NRG PALLAS offers excellent employment conditions:

- 27 vacation days and 12 ADV days;
- 8.3% year-end bonus and 8% holiday allowance;
- Pension with ABP, with NRG PALLAS covering 70% of the premium;
- Travel allowance of € 0.25 per km (max. 50 km one way) or full public transport reimbursement;
- Option to buy or sell leave days;
- Possibility of obtaining mobility budget or relocation allowance.

Personal Development

- Comprehensive onboarding program;
- Annual training budget and opportunities for personal growth.

Fun Activities

- Regular social and sporting activities;
- Lunch in our staff canteen;
- Working in a pleasant environment close to the dunes, woods and beach.