* Support in change management using the ADKAR methodology.* Compliance support to manufacturing sites before external inspection (e.g FDA cGMP audits)* Support in new business development for Avertim* Mentoring activities in the field of pharma industry to support efficiency increase, quality mindset and behavior.* Development of methodologies to optimise cGMP mindsets* Support the teams in the change management deployment* Deployement of EDMS in a GxP envirnment.* Management of documentation lifecycle, setup of KPI's and Metrics, improvement of the lifecycle.* Approval (audit) and maintenance of new and approved suppliers against GMP, ISO and MDD guidelines.* Development of quality agreements with suppliers, due diligence, on-cause audit,... * Setup and deploy in Supplier Quality system. * Support the manufacturing QA and the Regulatory team in CTD modules 3.2.S preparation. * Representative in the APIC association * Technical expertise in the field of Drug Delivery by participating in multifunctional / multi-disciplinary project teams in the evaluation, selection and adaptation of various engineering and/or research techniques.Specialties: Large experience in R&D (from analytical method development, stability studies to project management); Certified project manager (Pmp); Qualified lead auditor; Knowledge of EDMS; • Large network (e.g. within the European API suppliers community)• Strive for continued excellence. • Strong communication skills. • Self-starter. • Eager to learn new things. • Well-spoken, energetic and confident.Broad knowledge of regulatory affairs submissions processes
Listed skills include Quality Assurance, Bpf, Gmp, Mentoring, and 8 others.