Job description
Mission description:
* Provide operational and technical support to the TRD GMP WN31 site for the Electronic Batch Record (eBR)
* Manage and update regulatory documentation (URS, training packages, test protocols, global business documents)
* Define and monitor user requirements for media and substance preparations
* Prepare and execute formal and informal tests, ensure incident tracking and resolution
* Analyze the impact of changes on processes and documentation
* Deliver first-level support to end users, organize workshops, training sessions, and production visits
* Harmonize practices across different sites
* Ensure all updates are validated and approved in Veeva (document management tool)
Your profile:
* Experience with GMP documentation (User Requirements, Test Cases, Training Packages, Risk Assessments, Audit Trail, etc.)
* Knowledge of tools such as Veeva (document management, validation, compliance tracking)
* Skills in functional testing (preparation, execution, incident tracking, requirements writing)
* Academic background: higher education in sciences, engineering, quality, or pharmaceutical field
* Fluent English and French
* Mastery of best practices in computer system validation (CSV) and pharmaceutical regulations (FDA, EMA, etc.)
* Ability to work as an interface between business and technical teams, as well as with end users
* Experience with generative AI tools (if relevant)
* You demonstrate rigor, autonomy, and excellent communication skills
What we offer:
* An international community, bringing together 110+ different nationalities
* An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
* A robust training system with our internal Academy and 250+ available modules
* A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
* Strong commitments to CSR, notably through participation in our WeCare Together program
Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.