- Experience 3 à 5 ans 6 à 10 ans
- Type de fonction Qualité, Sécurité & Environnement
- Region Wallonie
- Activité Biotech
Contact
Baptiste Vrignaud
Email
+32 (0)472 88 76 22
Based in Ans, Trasis is an innovative and fast-growing MedTech active in nuclear medicine and radiopharmacy. Its aim is to give the medical and scientific community access to new treatments and diagnostic tools for (a.o.) cancer, Alzheimer's and Parkinson's disease.
Trasis develops and sells medical equipment worldwide. This equipment is used in hospitals, research centres, radiopharmaceutical production facilities and pharmaceutical companies.
Over the next 5 years, Trasis aims to consolidate its position as a market leader. The company will therefore double its workforce, strengthen its global presence and diversify its product portfolio. To achieve this, the company is counting on a major innovation drive.
Trasis offers a young, friendly working atmosphere and a flexible, dynamic environment. For more information, please visit www.trasis.com.
In order to strengthen Trasis’ team, we are looking for a QC Manager – GMP Analytical Method (M/F).
Responsibilities
As QC Manager - GMP Analytical Method, you are responsible for the Trasis QC analytical method process. You lead a team and ensure that analytical methods to be used for quality control activities on Trasis consumables are technically appropriate and verified/validated according to current standards.
Your main responsibilities are:
- You guide, organize and motivate a team of Analytical Chemistry Specialists and Officers to carry out the mission of defining QC Analytical Methods and stability plans.
- You are responsible for developing the technical expertise and standards of Analytical Chemistry Specialists and Officers, in order to guarantee the mastery of analytical industrialization activities in a GMP environment.
- Together with other Trasis staff (R&D, QA, Regulatory, etc.) and customers, you contribute to the development of new product projects (specifications, costs, deadlines, etc.).
- You are responsible for planning and carrying out the verification/validation of analytical methods and stability plans for the various Trasis projects within the deadlines set, in agreement with the project managers.
- You guarantee the application of the required quality standards (GMP standards, Trasis quality management system, QC procedures, etc.) in the process of defining QC Analytical Methods and stability plans.
- You assess the resources (people, equipment, materials, etc.) needed to complete the various analytical projects.
- Together with your team, you identify opportunities to improve analytical methods for the purposes of optimization or remediation.
Profile
- You have a Master’s or PhD degree with a scientific orientation (Chemistry, Biochemistry…).
- You have at least 3 years’ experience in team management.
- You have experience in an industrial biotech/pharma GMP environment.
- You have experience of managing analytical method validation and transfer projects.
- You have a good command of French and English.
- You demonstrate leadership skills and enjoy working as part of a team.
- You are proactive, resilient and assertive.
Offer
- The opportunity to work with cutting-edge technologies and to contribute to the improvement of cancer diagnosis and therapy techniques.
- The opportunity to participate in building and improving processes in a growing company.
- 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.
Your application and related information will remain strictly confidential.