Responsibilities

You actively participate in the establishment of applicable documents according to the product and/or infrastructure and/or improvement project (Quality agreement, protocols, batch record, etc.).
You align with Project Managers to identify quality requirements, regulatory strategies and product acceptance criteria.
You participate in the processing and follow-up of quality requests and in the definition of regulatory strategies. Within the framework of customer files.
You review and approve production, quality control and CoAs/CoC files for batches of consumables.
You ensure the completion, including the coordination of investigation and correction actions, and the closure of Quality Events in connection with projects.
You participate in risk analyses (products/processes, etc.).
You participate in setting up performance indicators to monitor operations within projects (reporting and KPIs).
Participate in the preparation and conduct of external audits (customers and authorities). You follow up on actions taken.
You participate in the qualification process for subcontractors and suppliers (QAA, audit, etc.).
You take part in drafting Product Quality Reviews (PQR).

Profile

You have a Master’s degree with a scientific orientation.
You have at least 3 years’ experience in a similar position.
You have experience in a QA role with a broad vision of regulatory and quality requirements. Expertise in the radiopharmaceutical sector is a plus.
You have experience in cross-functional management and project management.
You have experience in risk management and a good knowledge of GMP/ICH standards.
You have a good level of written and spoken English.
You are precise, methodical and autonomous.
You are assertive, organized and have a sense of priorities.

Do you want to become a major player in the global fight against cancer?

At Trasis, we give you the opportunity to work with cutting-edge technologies and to contribute to the improvement of cancer diagnosis and therapy techniques. Through your actions, you will have the opportunity to have a positive impact on the services provided to users and patients.

The opportunity to participate in building and improving processes in a growing company.

We offer a young and friendly work atmosphere, a flexible and dynamic environment.

An attractive and flexible salary according to your experience and performance, with extra-legal benefits.

QA Project Specialist

QA Project Specialist