Stellen Detail, K-Recruiting - DIE BESTE LÖSUNG ODER NICHTS.
Stellen Detail, K-Recruiting - DIE BESTE LÖSUNG ODER NICHTS.
Stellen Detail, K-Recruiting - DIE BESTE LÖSUNG ODER NICHTS.
ID EXISTS
POS 3490
Status 5
DJM 1

Quality Expert Medical Devices

Beschreibung: For one of our Swiss Pharma clients we are looking for temporary support as: Quality Expert Medical Devices (M/F/*)
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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.
  • 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.
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Qualifications:
  • 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 maria.haushofer@k-recruiting.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)
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Interesse geweckt?
Auf geht's!
Beginn: asap
Laufzeit: until 31.08.2020
Einsatzort: Basel, Switzerland
WhatsApp-Service: Mit WhatsApp zum nächsten Projekt!

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