Ingénieur Assurance Qualité

Description de l'offre

Mission: As QA expert, you will ensure that each medicine reaching a patient is safe, effective and of good quality and to have quality operations that support those objectives
Your next challenge will include the following responsibilities:

Lead, design & manage quality programs, policies, processes, procedures and controls. You will deal with the Quality policy & objectives and document those.
Write & update SOP’s, training materials & other cGMP related documents and you will manage documentation in conformance with SOP’s.
Perform GMP compliance operations including batch record review, evaluation of incident reports & follow up with all respondents, shop floor in conformance with SOP’s.
Design protocols, analyse data’s & perform audits and inspections to check conformance.
Participate to investigation of deviations in a cross-functional team environment and you will approve them.
Seek resolutions and answer customer complaints.
Bring CAPA solutions coming from deviations, complaints, audits & ensure its correct implementation & follow up.
Analyse, review and approve change controls.
Create or review Product Quality Review.
Create and review Quality Agreement to manage CMO.
Be QA responsible for product technical transfer.
Analyse and improve all quality systems.
Facilitate cross team meetings to find solutions.
Ensure that the performance & operations/products quality conforms to standards.

Profil recherché

You hold a Master degree in Biomedical or Pharmaceutical
You hold at least 3 years’ experience as QA
You are fluent in English, French and/or Dutch
Corporate values mean a lot for us. We expect them to mean something for you

À propos de Nalys

Nalys is a consulting group dedicated to high technology projects.
Thanks to our strong corporate values and adhocracy management, we are one of the fastest growing actors in engineering consultancy.
We gather great minds & challenge boundaries to help our customers developing stunning products. And we love doing it.

Discover how we can give a sense to your passion on www.nalys-group.com

Nalys is a people company. We will give you the opportunity to challenge yourself while doing something you love.
So whether you are a creative, a dreamer or an achiever, you can find a way to do something you truly enjoy.
And because we want our company values to be more than words, we invest 7% of our annual revenue to drive innovation,
develop your expertise, train your brains and give you time & tools to think big.