ABX GmbH
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
If you are interested in helping to shape the future of our company, we look forward to receiving your application documents by e-mail in pdf format, including information on 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 GmbH Heinrich-Gläser-Straße 10-14 01454 Radeberg Tel.-Nr.: +49 3528 40 41 66 E-Mail: bewerbungen@abx.de Homepage: www.abx.de
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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
If you are interested in helping to shape the future of our company, we look forward to receiving your application documents by e-mail in pdf format, including information on 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 GmbH Heinrich-Gläser-Straße 10-14 01454 Radeberg Tel.-Nr.: +49 3528 40 41 66 E-Mail: bewerbungen@abx.de Homepage: www.abx.de
#J-18808-Ljbffr