GMP & Compliance Project Manager in Radiopharmacy (m/f/d)
Our profile
ABX is a young, fast-growing chemical and pharmaceutical company based in Saxony, Germany. We are the global market leader in the production of precursors and kits for PET diagnostics. These are mainly used in the detection of tumours by positron emission tomography (PET). ABX currently employs around 400 people. Due to our strong market position we have a continuous profitable growth. Since 2007 we have been part of a large Japanese pharmaceutical group. We are looking for a GMP & Compliance Project Manager in Radiopharmacy (m/f/d) as soon as possible.The role holder is responsible for the technical coordination and implementation of GMP-related projects and ensures the compliant introduction of new facilities, equipment, processes, and infrastructure in accordance with applicable regulatory requirements. The position serves as a key interface between Operations, Quality Assurance, Engineering, and external partners.
We offer
- A modern working environment in the pharmaceutical industry
- A long-term and secure job in an expanding, future-oriented and internationally oriented company
- Full-time employment with an initial fixed-term contract with the express wish of a long-term cooperation
- Flexible working hours
- Job ticket / travel allowance / company bicycle
- Proximity to public transport (Radeberg railway station) and very good and fast connections to Dresden and the surrounding regions
- Free drinks and company events (summer party, Christmas party, departmental hiking days ...)
- Allowance for fitness and sports activities
Qualification
- Bachelor's degree or higher in a scientific or technical discipline, or an equivalent qualification
- Several years of professional experience in a GMP-regulated environment
- Solid knowledge of current GMP requirements, particularly the EU GMP Guidelines
- Experience in qualification and validation projects
- Initial experience in handling radioactive materials and compounds
- Structured, self-directed, and solution-oriented working style and ·strong communication, coordination, and organizational skills
Key Responsibilities
- Plan, coordinate, and implement GMP-related projects within manufacturing, cleanroom, and laboratory environments
- Ensure GMP-compliant project execution in accordance with applicable regulatory requirements and industry standards
- Prepare, review, and maintain qualification, validation, and project documentation
- Participate in regulatory inspections and audits
- Support risk assessments, change control processes, and CAPA activities
- Participate in regulatory inspections and audits and support the commissioning and qualification of new equipment, facilities, and processes
If you are interested in helping to shape the future in our company, we look forward to receiving your application documents by e-mail in pdf format with information about your salary expectations and the earliest possible start date. Ms Stephanie Ziesche will be happy to answer any technical questions you may have, and Ms Conny Hochmann will be happy to answer any questions about the application process.
Contact
ABX advanced biochemical compounds -Biomedizinische Forschungsreagenzien GmbHHeinrich-Gläser-Straße 10-14
01454 Radeberg
Tel.-Nr.: +49 3528 40 41 66
E-Mail: bewerbungen@abx.de
Homepage: www.abx.de