Regulatory Quality Coordinator
Mid 2009, I joined the infarAMA team as Regulatory Quality Coordinator.
Mainly, as industrial pharmacist, my responsibilities reside in the duties as Qualified Person (either primary QP or back-up QP) for various clients.
This includes, amongst others, on-site visits, batch release, complaint handling, preparation of external audits, conducting internal audits and streamlining procedures.
In addition, I assist my colleagues with advice in the preparation and submission of the CMC part of regulatory files (new submissions, variations, publicity etc.)