Beschreibung
We are looking for a
Technical Project Manager (m/f)
Reference: -en
Start: asap
Duration: 6 MM
Place: in Coinsins
Branch: Wettbewerber
Your tasks:
- Lead and manage the development of leading-edge next generation Drug Delivery medical devices throughout the execution cycle from requirements through to product filing and market launch support
- Lead cross-functional and supplier activities to ensure delivery of product functionality, quality, and schedule within budget and with compliance to quality, regulatory and customer requirements
- Provide project plan, project risk log, action trackers and meeting minutes as well as dashboards for management reviews
- Manage global medical device development projects to successful launch, ranging from class I to sterile class III, standalone CE marked devices and combination drug device products
- Execute several medical device development projects in accordance with global IT/Quality standards, and industry standards (GMAP 5, EU Annex 11, 21 CFR 11) within the medical device engineering department
Your qualifications
- Master or PhD in Pharma, Life Sciences, Chemical Engineering
- Excellent knowledge in computer system validation, project management and analytical testing and method development
- Combination drug device product
- Strong knowledge in contracts and budget management, GAMP 5 , industrialisation and manufacturing and medical device design and development
- Experience in leading project teams
- Fluency in English
Skills:
- Qualification/validation specialist