↳Bachelor
↳Fundamental, broad understanding and knowledge of quality standards and policies in Drug Product/Medical Devices (combination products) manufacturing and control
↳Experience with Health Authority Inspections (FDA and EMA in particular), Notified Body inspections and knowledge of RegCMC requirements for NB, Health Authority submissions (INDs, IMPDs, NDAs, ANDAs, MAAs)
↳Broad experience in combination product development as well as in Quality Assurance and/or Quality Control departments
↳Experience in Technical Operations or equivalent experience from external company is preferred
↳Proven track record in successfully supporting interdisciplinary teams, e.g. scientists working on technical or methodological projects, in RnD or equivalent experience from external company or other line function
↳Ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills
↳Computer literacy (e.g. MS Office, document management systems) demonstrated along with readiness to learn new systems and associated processes
↳Fluent English required (oral & written). Good skills in site (local) language desired (oral)
