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Quality System Analyst
vor 2 Wochen
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
