Michael Bailey Associates - Munich Switzerland
We have an exciting contract opportunity open for a Packaging Project Leader in Switzerland. The ideal candidates should have good experience in Project Management Primary Packaging development projects. Experience in working with drugs and devices. Responsible: Lead the technical development of the packaging and/or drug delivery systems, from early phase up to commercialization. Responsible for leading the collaboration with the internal and the external partners. Provide primary packaging and device expertise in a broader cross-functional drug product development team. Supporting and coordinating the manufacturing of clinical material and the production scale up. Supporting cross functional project teams in the development, review and submission of regulatory dossiers. Managing and monitoring Human Factors Engineering activities. Leading Risk management activities. Planning and monitoring of design verification activities (in-house). Leading and authoring technical documentation. Ensuring a high quality Design History file. Transfer of Design History File to production. Required: Bachelor's or Master degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education Minimum 7 years of experience in leading device development. Strong technical background in medical devices and in pharmaceutical packaging development is crucial to support, monitor and challenge internal and external development partners. Experience in project/program management of complex projects. Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation). Development and writing of technical documentation of drug/device combination products and medical devices, including Design Control process and other applicable regulatory, QA and GMP aspects. Experience of managing external suppliers. Great communication skills. Kontak: Luchele Mendes Michael Bailey International is acting as an Employment Business in relation to this vacancy.