Jobdescription
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 investigationsEnsurance of accurate documentation and closure of each complaint in order to make and document sound regulatory reporting decisionsDevelopment of a detailed understanding of the products and previously investigated complaintsEvaluation of market impact of new complaints and escalation of critical issues for immediate actionReview and analysis of complaint information for trending / risk analysis and corrective actions and resultant effectiveness of these actionsSupport of internal, external, and third-party auditsSupport of additional project team activities and / or investigations, and participation in process improvement projectsQualifikationen
Who we are looking for :
A Masters's Degree, PhD or equivalent experience in engineering, physical, biological, natural sciences is requiredInvestigative & analytical critical thinking skillsStrong decision-making skills ? able to make sound business decisions with sometimes limited informationStrong written and verbal communication skills in EnglishWritten and verbal communication skills in German are of advantage1 year of experience in quality in a pharma / medical device or other regulated industry is preferred but not requiredKnowledge of statistical applications and auditing practices is preferred but not requiredThis 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!