Mechelen, Flemish Region, Belgium
Responsible for: - late stage drug product development (OSD) including formulation and process development - clinical trial manufacturing of (bulk) drug product (OSD) - paediatric formulation development Experience in: - QbD and DoE methodology used within drug product development - regulatory submissions writing (IMPD, IND, MAA, PIP) - engaging in and maintaining fruitful collaborations with CDMO's - design and validation of CMC department specific inventory software (GxP qualified)
Responsible for planning and reporting of CMC (Chemistry, Manufacturing & Controls) budgets and resources of multiple drug development projects.
As a pharmaceutical consultant, I gained experience in roles within quality assurance and manufacturing. This includes knowledge of change management, CAPA, supplier evaluation, risk management (focus on FMEA), periodic reviews (PQR) and stability studies. Furthermore, aseptic manufacturing of sterile medicinal products (Eudralex volume 4 annex 1) and IMP production (Eudralex volume 4 annex 13) are familiar to me with focus on sterile filtration and aseptic techniques used in manufacturing ATMPs.
Responsible for: - Design and transfer of sterile filtration process from development to GMP - Technical writing of production documentation - Technical writing of process validation documentation - Writing and revision of Master Batch Records - Lead + participate in production-related root-cause investigations
Experience in: - Technical writing of production and equipment documentation - Quality Risk Management using FMEA technique - FAGG Audit-readiness preparation
Department: Part & Product Availabilty (Supplier QA) Experience in: - Material specifications of incoming materials - Supplier evaluation - Quality risk management of warehousing processes