Qualified Person (QP) 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. To support our team, we are looking for a Qualified Person (m/f/d) for our Radiopharmacy department to implement the batch release of radiopharmaceutical products and further develop our quality management system (QMS) 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
- University degree in chemistry, pharmacy, medicine, pharmaceutical chemistry, biology, or a comparable field
- Experience as a Qualified Person in accordance with the German Medicines Act (§14 AMG), ideally for radiopharmaceuticals or injectable preparations
- In-depth knowledge of pharmaceutical manufacturing, quality assurance, and regulatory requirements
- Several years of practical experience in the quantitative and qualitative analysis of radiopharmaceuticals
- Sound understanding and application of GMP and regulatory guidelines
- Very good written and spoken German and English
- Team player with technical understanding and problem-solving skills
- Organizational talent with a high level of attention to detail, strong communication skills, and a sense of responsibility
Task
- Ensuring that medicinal products are approved for distribution in accordance with legal regulations and guidelines
- Reviewing and approving batch reports, analysis data, and production-related documents
- Investigating and processing deviations and implementing corrective measures in the manufacturing process
- Participating in internal and external audits of production facilities and quality systems
- Providing technical advice to internal teams on regulatory requirements and quality standards
- Optimizing processes to increase QMS effectiveness
- Supporting site management in quality-related tasks and projects
Contact
ABX advanced biochemical compounds -Biomedizinische Forschungsreagenzien GmbH
Heinrich-Gläser-Straße 10-14
01454 Radeberg
Tel.-Nr.: +49 3528 40 41 66
E-Mail: bewerbungen@abx.de
Homepage: www.abx.de