QA Pharma Complaint Specialist

vor 1 Woche

Schaffhausen, Schaffhausen, Schweiz SIGMA7 GmbH Vollzeit CHF 80'000 - CHF 120'000 pro Jahr
QA Pharma Complaint Specialist (m/w/d) // Johnson & Johnson 5 Tage alt Angaben zum Job Firma Job-Inhalt

Caring for the world, one person at a time … inspires and unite the people of Johnson & Johnson, we embrace research and science- bringing innovative ideas, products and services to advance the health and well-being of people.

High quality is built into all manufacturing and quality processes, yet still products are sometimes reported by our patients in a state that is not in line with our expectations. To ensure continued manufacturing process improvement and to address potential patients risks Product Quality Investigations are led by QA Pharma Complaints Specialists based on the feedback received from our patients.

Main responsibilities:

  • Investigation of product quality concerns based on customer complaints
    Assessment, coordination and/or investigation of assigned customer complaints
  • Inspection of returned products, investigation of technical details, and root cause analysis, risk assessment, and assist/lead associated CAPA investigations
  • Ensurance of accurate documentation and closure of each complaint in order to make and document sound regulatory reporting decisions
  • Development of a detailed understanding of the products and previously investigated complaints
  • Evaluation of market impact of new complaints and escalation of critical issues for immediate action
  • Review and analysis of complaint information for trending/risk analysis and corrective actions and resultant effectiveness of these actions
  • Support of internal, external, and third-party audits
  • Support of additional project team activities and/or investigations, and participation in process improvement projects

Qualifikationen

Who we are looking for:

  • A Masters's Degree, PhD or equivalent experience in engineering, physical, biological, natural sciences is required
  • Investigative & analytical critical thinking skills
  • Strong decision-making skills ? able to make sound business decisions with sometimes limited information
  • Strong written and verbal communication skills in English
  • Written and verbal communication skills in German are of advantage
  • 1 year of experience in quality in a pharma/medical device or other regulated industry is preferred but not required
  • Knowledge of statistical applications and auditing practices is preferred but not required

This position is based in Schaffhausen, Switzerland and will initially be limited to approx. 12 months. If you are interested in working for a global leading health care company in a challenging role, then send us your application in English today. Or give us a call if you have any questions

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