Beschreibung
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.