Quality Assurance Engineer (M/F)

European industry is transforming. The capital is there, the projects are too. But on the ground, the essential is missing: the skills to run the lines. It is to respond to this context that Kali Group exists. We are a consulting firm 100% specialized in operational manufacturing. From industrialization to modernization, we solve the challenges imposed by factory complexity in Aeronautics, Nuclear, and Life Sciences. Our strength is our community. At Kali Group, every specialist is part of a collective of experts who share their feedback, methods, and solutions. You are never alone when facing a problem. When you are stuck on a subject, another member of the community has already solved it elsewhere. It is this collective intelligence that makes us different. Our ambition: To develop THE community of manufacturing specialists and become the European operational reference.

The position:

An industrial site in full transformation: internalization of a production line for consumables for the pharmaceutical industry. You will be the site's sterilization technical referent, the one the organization relies on to master, structure, and implement the regulatory requirements of Annex 1 GMP.

Concretely, this involves taking charge of the sterilization aspect in a context of line internalization, from the qualification phase to compliant operation:

• Define and drive the sterilization strategy adapted to consumable products (cycles, parameters, validation methods)
• Write, execute, and close sterilization process validation protocols (IQ/OQ/PQ) in compliance with the revised Annex 1 GMP (2022)
• Be the reference interlocutor during ANSM, FDA audits, and client inspections
• Manage deviations, CAPA, and change controls related to sterilization equipment and processes
• Contribute to the skill development of site teams regarding GMP sterilization requirements

Profile sought:

• Master's degree (Bac +5) in pharmacy, process engineering, or equivalent training
• Minimum 5 years of experience in a GMP environment, with confirmed mastery of Annex 1 GMP - this is the non-negotiable criterion
• Practice of associated frameworks: CCS (Contamination Control Strategy), sterilization validation, GMP document management
• Professional English (reading regulatory docs, exchanges with auditors)
• Real autonomy: you will be the expert.