Transfer Production Coordinator (F/M/X) - Diagnostics division
The Transfer Production Coordinator transposes the R&D process into a Production process and develops procedures, work instructions and production forms in compliance with internal procedures and quality standards (ISO 13485) and within defined deadlines.
- Write, adapt and implement the transfer documentation including the definition of acceptance criteria:
- Device master record;
- Protocols for Oligo / master cell / plasmid / transcript / reagent preparation;
- Plan and perform molecular biology tests (protocols, reports, specifications, ...);
- Inventory of raw materials needed for production (BOMs);
- Procedures, work instructions and work forms for manufacturing;
- Train and assist the production team on the output of the transfer documentation.
- Assist the QC department in the implementation of the protocols related to the different QCs to be carried out on the products under development;
- Assist the validation team in the implementation of the protocols related to the validation of the products, process and equipment;
- Ensure the technical improvement of products currently on the market and existing production processes;
- Ensure communication of production times with the PMO and QC department;
- Apply and respect the quality rules implemented by Diagenode Diagnostics in accordance with the ISO 13485 quality standard and regulations issued by the various authorities.
- Master's degree in biology, molecular biology, bio-chemistry or equivalent
- Proficiency in molecular biology techniques (qPCR and extraction)
- Knowledge of product validation and transfer principles
- 1-5 years of experience in a similar field and work experience in ISO 13485 environment
- Languages: French and English
- Good knowledge of the Office Suite
- Team spirit, rigorous, dynamic, enthusiastic and excellent ability to communicate
- Organized, autonomous, good planner, able to handle multiple tasks in parallel