Qc Device

We are looking for a looking for a high caliber, self-motivated **, QC Device & Packaging Project Manager **To strengthen our **Internal Manufacturing **team **, based in our UCB Campus based in **Braine l'Alleud, Belgium.
**About the role**
As our new team member:

- You facilitate the analytical transfer of the new products to the Quality Control laboratory (i.e. plan the activities with SME analysts and team lead, review protocol, data and reports of the analytical transfer, escalade issues or roadblocks, equipment needs to the Scientist) for the functionality testing on medical Devices. You also participate to the validation of methods if needed.
- You are part of the creation of development & commercial specification with the different stakeholders.
- You are a project leader for the installation and qualification of new lab equipment. You train technicians to the utilization of these new equipment.
- You lead investigations in term of visual inspection of our injectables products and identification of particles.
- You participate to all meetings with stakeholders (Development analytical lead, Industrial analytical lead, supply, Manufacturing NPI, stability lead, validation, instruction analytical and coaching) in term of planning and samples follow-up (i.e., shipment and reception)
- You coordinate all studies (release, stability studies, analytical instruction, coaching, process validation, etc through lims or requests of analysis) asked by the stakeholders, you ensure the follow-up and communicate the results
- You smoothly communicate internally within the Quality Control lab team urgencies and priorities asked by different stakeholders to adjust the planning with the Team leads.
- You work in close collaboration with SME for local specification creation or update.
- You handle actions, deviations and realize investigations based on QBD within the laboratory in close collaboration with team leads and QA team member (with Trackwise/Source and LIMS systems)
- You report to the Head of laboratory. You work in close collaboration with Team leaders, scientist and technicians of the laboratory (transversal matrix).
- You increase expertise in the laboratory by training technicians to analytical techniques as well as support troubleshooting

**Profil**:

- This position requires a master or graduate degree required in bioengineering, microbiology, molecular biology, analytical chemistry applied to aseptic and/or biological products or equivalent with demonstrated experience in packaging or particles inspection.
- You have an expertise in the pharmaceutical analysis of, preferably, Medical Device and/or New Biological Entities.
- Areas of expertise on specific technologies applied to new products are force bench, control of primary packaging articles, control of secondary packaging articles, Programming knowledge is an asset, functional testing, particles identification etc.
- You have proven experience in the GMP environment.
- LIMS software for sample management and proven experience on the use of Trackwise/source software for deviation management are an asset.
- You have proven project leadership skills including planning, monitoring, issue resolution, investigations (DMAIC, 5M, etc), decision making and reporting.
- You have a proven experience of 2-3 years in analytical transfer between development to QC.
- You have strong organization skills with proven records.
- Green belt ownership or training in Root cause analysis are assets.
- You have an understanding of all analytical disciplines related to CMC for late stage development and commercial products (analytical development, stability testing and quality control of drug substance, drug product, raw material and intermediate).
- Knowledge or experience of an implementation and maintenance of 5S mind set and environment is an asset
- You have a "Green" mind set
- You speak, write on a professional level in French and English