Project Manager GMP & Compliance 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 Project Manager GMP & Compliance in Radiopharmacy (m/f/d) as soon as possible.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
- Completed degree in a natural science or technical field or a comparable 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, independent, and solution-oriented approach to work
- Strong communication and organizational skills
Task
The position holder is responsible for the technical coordination and implementation of GMP-related projects and ensures that new equipment, processes, and infrastructure are introduced in compliance with regulatory requirements. In this role, he or she serves as the liaison between operations, quality assurance, engineering, and external partners. The specific responsibilities are as follows:- Planning, coordination, and implementation of GMP-related projects in production, cleanroom, and laboratory environments
- Ensure GMP-compliant project execution in accordance with regulatory requirements
- Preparation and review of qualification, validation, and project documentation
- Coordination of internal and external project participants
- Support for risk analyses, change control procedures and CAPA actions
- Assisting with regulatory inspections and audits, as well as overseeing the commissioning of new facilities, spaces, and processes
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