Quality System Analyst

vor 1 Woche

Le Locle, Neuenburg, Schweiz Randstad Switzerland Vollzeit

On behalf of our client, we are looking for a QS Analyst (Training & Document Control).

Contract: Temporary unlimited

Location: Le Locle

Home office: max 1 day per week

Availability: ASAP or with maximum 1-month notice

Languages: French and English fluency required

Responsibilities

  • Manage and maintain the electronic training system (assignment, data entry)
  • Support the maintenance of the document control system
  • Manage circulation of documents for approval
  • Review electronic documents submitted to document control for correct formatting, spelling and clarity of text before releasing as approved documents
  • Maintain revision and approval status of all documents
  • Maintain appropriate form templates for access
  • Participate in quality system management
  • Coordinate classroom training sessions
  • Support during internal and external audits with the required training records or information
  • Create documentation & procedures related to its position
  • Assist with document update and translation

Requirements

  • Minimum of 1-2 years' experience in document and promotional materials management using electronic document management systems (Agile or Adaptiv or other PLM system)
  • Minimum of 1-2 years' experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably in the medical device or pharmaceutical industries
  • Minimum of 1-2 years' experience in a Learning Management System (LMS) and its use to deploy training programs and requirements across the company
  • Knowledge or experience working in an FDA and/or European regulatory environment
  • Thorough understanding of GMP (Good Manufacturing Practices)/ISO (International Organization for Standardization) regulations
  • Written and verbal effective communication skills in English and in French including presentations as assigned
  • Proficient in Microsoft Office tools - Word, Excel, and PowerPoint
  • Solid document management skills
  • Strong communication, organizational, negotiation and interpersonal skills
  • Autonomous / Conscientious / Rigorous / Analytical Mind / Flexible
  • Well organized and systematic approach
  • The ability to collaborate with all levels of management across multiple sites and functions

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