Brussels, Brussels Region, Belgium
- Managing the project by handling multiple priorities, provide leadership, organize the activities in relation with the department activities (release, stability, specification, comparability, reference standard strategies). - Preparing (or support the review) protocols/reports and any required documentation related to clinical stability, release and specification activities. - Provide support for analytical troubleshooting related to the project. - Supporting regulatory submissions by providing in timely manner the key deliverables and supporting the requests from Health Authorities. - Interacting with key stakeholders: Commercial QC, RA, QA...
I had the opportunity to travel around Argentina, Chile, Colombia and Ecuador for 13 months. Through some volunteering work in natural reserves and farms, I learned a lot about local cultures and histories and met people that gave me the chance of living unforgettable experiences in the countryside.
• Preparing/reviewing stability or comparability protocols • Analyzing results • Verifying data • Validating results within Lims system • Preparing/reviewing stability or comparability reports and certificate of analyzes • Following deviations and incidents • Preparing/reviewing specification and associated justification of specifications • Ad hoc presenting/discussing results in project team meetings.
Projects coordination: • Results follow-up and presentation in international meetings • Collaboration with other teams and departments (e.g. Regulatory Affairs, Analytical, Supply, QA) • Participation in risk assessments (FMEA) • Process development at laboratory scale (liposomes production) • Responsible for productions at pilot scale • Review of validation documents • Scheduling, supply GMP Quality handling: writing deviations, procedures, leading investigations, working in SAP Work in the field: leading manufacturing processes in pilot plant, start of a new equipment in the laboratory, manufacturing support