Description

On behalf of our client, we are looking for a QS Analyst (Training & Document Control) for a temporary contract of 6 months (extension unlikely).

 

Location: Le Locle

Contract: Temporary – 6 months

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