Carla has experience in supporting pharmaceutical industries within R&D focused product development, where she has coordinated with multiple international teams. She has supported multiple projects through development and implementation phases of the product lifecycle: including product stability, application testing, product validation, transfers to manufacturing, and product troubleshooting.
Her work has encompassed a wide range of responsibilities including design of experiments in a wet lab environment, finalising D/P FMEAs and risk assessments, writing validation and change control documentation, initiating process improvements, and training manufacturing teams on new processes. She has extensive experience in technical writing, having authored countless SOPs, WIs and other GMP documentation. Carla is adaptable, friendly, and is comfortable working under ISO 9001, ISO 13485, and GMP environments.