Beschreibung
Medical Device Change Control Expert wanted for our Basel based client in the pharmaceutical sector.Your experience/skills:
- Master degree in Science or Engineering with 5+ years' experience in related field
- Working experience in managing medical device and combination product Change Controls as well as pre-filled-syringe device development, from early phase activities up to commercialization and production scale-up
- Familiarity with medical device quality assurance and medical device regulations, ISO13485
- Understanding of DHF compilation, including Design Control process and other applicable regulatory, QA and GMP aspects
- Basic understanding of pharmaceutical development, of Human Factors Engineering and Risk management as well as of manufacturing
- Languages: fluent English both written and spoken
Your tasks:
- Managing change control activities within the development and life cycle management of parenteral delivery systems, such as drug or device combination products and medical devices
- Rolling out of new change control process including training of personnel on process and systems
- Collaborating with team members across sites to ensure quality documentation meeting all regulatory requirements
- Working with a team to understand and remove roadblocks in completing changes
- Reporting KPIs to ensure timelines of change control actions
Start: ASAP
Duration: 06MM+
Location: Basel, Switzerland
Ref.Nr.: BH13192
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
Going the extra mile…
New to Switzerland? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more