Responsibilities

You ensure the smooth running of GMP consumables production processes (APIs, reagents and packaging).
You are responsible for organizing activities on the API and aseptic line production premises.
You are responsible for production reporting, and will take part in setting up and monitoring KPIs.
Check that production-related documents (logbook, etc.) are properly completed.
You draw up and adapt quality procedures and other documents relating to GMP production.
You ensure compliance with storage conditions for materials and products. You organize the practical aspects of cleaning GMP production areas (planning, improvements, etc.).
You actively participate in, validate and authorize qualification/maintenance operations on premises and equipment.
You review and close MBRs and PBRs (including deviations, change control, etc.) to authorize QA release “on time”. You participate in the drafting of MBRs and PBRs based on specifications defined in collaboration with the industrialization team, and are responsible for ensuring the relevance of the information collected.
You participate in the implementation of GMP production flows and ensure their sustainability.
You take part in risk analyses (products, processes, etc.). You take part in investigations and impact analyses of deviations and in defining and implementing associated CAPAs.
You ensure compliance with safety regulations and identify and implement any necessary changes and improvements.
You ensure that the initial and ongoing training required for GMP production team members is carried out and adapted as necessary.

Profile

You have a Master’s degree with a scientific orientation, or equivalent through experience.
You have a working knowledge of GMP standards.
You have experience in aseptic production.
You have a good level of English.
You demonstrate leadership and assertiveness.
You are autonomous, rigorous and precise.
You are organized and proactive.
You enjoy working as part of a team.

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.

GMP Production Specialist

GMP Production Specialist