Transfer Production Coordinator (F/M/X) - Diagnostics division

Job description

Mission

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.


Key responsibilities

  • 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.


Job requirements

  • 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


Location

Seraing, Belgium