Aktuelle Jobs im Zusammenhang mit Quality Management System Expert - YverdonlesBains, Waadt - Michael Page

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    {"h2": "Validation Specialist - Pharmaceutical Industry", "p": ["Our client, a leading biopharmaceutical company, is seeking a skilled Validation Specialist to join their team. As a key member of the Center of Excellence for projects and New Product Introductions (NPIs), you will be responsible for ensuring products and processes meet regulatory requirements...

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    Yverdon-les-Bains, Waadt, Schweiz gloor&lang AG Vollzeit

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    vor 1 Woche


    Yverdon-les-Bains, Waadt, Schweiz gloor&lang AG Vollzeit

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  • Senior CSV Specialist

    Vor 6 Tagen


    Yverdon-les-Bains, Waadt, Schweiz gloor&lang AG Vollzeit

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  • IT Bioplant Engineer

    Vor 6 Tagen


    Yverdon-les-Bains, Waadt, Schweiz Incyte Vollzeit

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  • IT Bioplant Engineer

    vor 2 Wochen


    Yverdon-les-Bains, Waadt, Schweiz Incyte Vollzeit

    Job SummaryWe are seeking a highly skilled IT Bioplant Engineer to join our team at Incyte. The successful candidate will be responsible for managing and supporting the technical components of our manufacturing systems, laboratory equipment, and infrastructure.Key ResponsibilitiesInstall and administer equipment in the Bioplant Process Science and Quality...

Quality Management System Expert

vor 3 Monaten


YverdonlesBains, Waadt, Schweiz Michael Page Vollzeit
  • Lead identification, development, architecture, and optimizations of the Quality Management System, at both Global and Site levels.
  • Work collaboratively and support process owners in reviewing, structuring, and documenting their functional new or improved processes.
  • Analyze existing processes and ensure integration and consistency across shared, linked, and cross-functionally dependent processes.
  • Author procedures, policies, work instructions, and related documents with style, content, and format guidelines in compliance with ISO 13485, 21CFR820, EU MDR and other applicable regulations.
  • Actively monitor effectiveness of the quality management system and propose and execute improvement projects.
  • Lead complex quality initiatives (e.g. CAPA, process improvements, new processes, gap analyses, system integrations), make recommendations, develop and execute plans.
  • Plan and conduct internal audits by participating and leading internal audits, follow up on the findings with auditee through effective closure, and present the data for trending.
  • Support electronic QMS transition and take ownership of the software tools including QMS documentation and change control.
  • Degree in Engineering, Scientific.
  • 7+ years of quality-related system experience in a medical device company developing medical devices.
  • Excellent technical writing, proofing, and language (grammar and spelling) skills with strict attention to detail.
  • Significant knowledge of medical device Quality Management Systems (ISO 13485, 21 CFR 820) and regulatory landscape (i.e. MDR).
  • Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills.
  • Advanced problem-solving, organizational, analytical and critical thinking skills.
  • Certified lead auditor.
  • Electronic QMS experience is preferred.
  • Excellent command of English language.