QA Manager
Il y a 2 mois
**Company**:
Our client is an ambitious start-up supported by strong private and public investors.
This company aims to provide an innovative solution to the production problem in the field of cell therapy. Indeed, through the optimization of exosomes, this company offers a versatile technological platform with a therapeutic purpose.
To strengthen their team, they are looking for a QA Manager to set up the quality structure of the company. You will report to the CTO and the management board who have an extensive experience in the pharmaceutical sector.
**Role**:
Your responsibilities will be:
- Implementation and transversal management of the Quality System (QMS and Documentation Management) in order to meet, on a long-term, GMP standards.
- Writing and implementation of procedures in close connection with the scientific team
- As the company works with subcontractors, you will be in charge of auditing them but also challenging them on a daily basis about quality issues.
- You support Validation Master Plan and Process Validation
- Risk Management
- As the company is growing, you will be in charge of the development of e-learning to facilitate onboarding process.
**Profile**:
- You have a proven experience in Quality Management in a GMP environment (at least 5 years)
- You have developed good writing skills and you work with structure
- You own a scientific Background in the biopharmaceutical field
- Problem solver, you have the ability to find solutions and to bring new ideas.
- You are a good communicator and your flexible
- You are fluent in English. French is a big asset
- You are flexible to start with a part-time (3/5) and the to evolve to a full time (by the end of 2023.
- The company is located in Gosselies (offices) but works in close collaboration with the KUL. Therefore, you are flexible to move from a office to an other. Homeworking is also foreseen.
**Offer**:
We offer the opportunity to join a promising company and write a part of its history.
The company is open to freelance or employee status for which they offer a complete package.
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