Beschreibung:For one of our Swiss Pharma clients we are looking for temporary support as:Quality Expert Medical Devices (M/F/*)
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.
Release of medical devices for clinical studies and commercial use.
Support Medical Device Risk Management, through proactive risk management tools and approaches, to minimize impact on global supplies and patients.
Perform or support inspections and audits
Coach and develop people; participate in recruitment of talent
Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority requirements, SOPs, HSE, etc.).
Lead and support direct reports in line with company values and behaviour including objectives setting, performance evaluations, development planning and participate in recruiting process.
Start: asap // Duration: until 31.08.2020 // Capacity: 60 - 80 % workload onsite (in the beginning remote due to COVID-19)
Graduate in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science
At least 3 years of experience in hands-on medical device development (R&D)
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
Ability to influence people, negotiate and communicate.
English fluent in speaking / writing, German and/or French desirable
Bemerkungen:WANTED Quality Expert Medical Devices (M/F/*). In case of interest please contact email@example.com or +49 89 18 90 998-30. Skills:Biotech, cGMP (Current Good Manufacturing Practice), Chemist (Biochemist/ ChemEngineer), English, GMP (Good Manufacturing Practice), Medical Devices, Microbiologist / Microbiology, Pharma, QA (Quality Assurance), QC (Quality Control)
Unsere Webseite nutzt Cookies. Wenn Sie diese Webseite nutzen, gehen wir von Ihrem Einverständnis aus. Sie können unsere Cookies löschen. Wie das geht, erfahren Sie in unserer Datenschutzerklärung.OKDatenschutz