Fast Track Diagnostics, a Siemens Healthineers company, develops and commercializes worldwide multiplex real-time PCR (RT-PCR) assays to detect a wide range of viruses, bacteria, fungi and parasites. We are ISO 13485 certified since 2011. Our kits are used in all size labs, in the public and private sector. In the last years, FTD created a global distributor network that serves many countries worldwide. Growth has been at least 30% year on year since the company was founded in 2007. Quality, innovation and excellent customer support are our key objectives.
We offer a job in an international, highly qualified team.
Stability Scientist - (M/F)
- Work as member in the quality management and quality control department
- Support the QM and QC team in the tasks of generating and updating all relevant documentation (SOP, process instructions, manuals, etc.) according to the ISO 13485
- Ensure the successful completion of equipment qualifications, process validations if needed
- Responsible for equipment monitoring, calibration and support maintenance if needed
- Stability studies
- Management and update of certain quality relevant documents (e.g. development of sheet, table with sequences, tables with targets)
- Random controls of produced products (RTU, ready kits).
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience
- Prior manufacturing or quality experience in molecular diagnostics is an asset
- Good working knowledge of DIN EN ISO 23640, IVD medical devices and evaluation of stability of IV diagnostic reagents (ISO 23640:2011)
- Knowledge of quality requirements (ISO 13485)
- Driven individual with a history of developing collaborative, cross-functional solutions
- Strong focus attention to details
- Advanced knowledge of EXCEL and good command of MS office
- Excellent written and spoken English language skills
- Capacity for working independently
- Excellent interpersonal and organizational skills
- Will to work in an international team within a highly collaborative environment.
The position will be based in Luxembourg.
If you feel that our job profile matches your qualifications and personality, please do not hesitate and send us your application in English, including CV, covering letter and your expected salary, by post or email to the following address:
Fast-track Diagnostics Sàrl.
Ms. Elisabeth CHACTOURA
29, rue Henri Koch- L-4354/ Esch s/ Alzette
For more information please visit our web site: www.fast-trackdiagnostics.com