Description
We are looking for a
Quality Expert for Medical Devices (NOVJP) (m/f)
Reference: -en
Start: 03/18
Duration: 10 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Manage portfolio of assigned projects, support a discipline and/or provide a service on his/her own or with a team of associates
- Provide functional expertise in area of responsibility for medical devices and combination products
- Write, Review and approve deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance
- Accountable for monitoring, analysis and reporting of GMP related KPIs as part of management reporting
- Manage quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies
- Release of medical devices for clinical studies and commercial use
- Perform or support inspections and audits as required
- Lead project related activities (e.g. development of new tools, processes)
Your qualifications
- Graduate in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science
- Ability to influence people, negotiate and communicate
- Excellent knowledge of cGMP, working knowledge of medical device and combination product regulations, standards and guidelines
- Good knowledge of medical device development and life-cycle management
- Good and proven ability to analyse and evaluate GMP compliance
- English fluent in speaking / writing, German and/or French desirable
Skills:
- Quality manager