Description
We are looking for a
Quality Expert for Medical Devices (m/f)
Reference: -en
Start: asap
Duration: 7 MM+
Place: in Basel
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 your own or with a team of associates
- Provide functional expertise in the 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
- 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
- Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority requirements, SOPs, HSE, etc.)
- Promote and enforce compliance with guidelines
Your qualifications
- Degree in Chemistry, Pharmacy, Microbiology or Biotechnology or in another related science
- Solid relevant experience
- Sound scientific, technical and regulatory knowledge in a specific area
- 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 management employee
Keywords: Mitarbeiter Qualitätsmanagement