Quality System Analyst

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

Contract: Temporary – 6 months, via Randstad

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
• 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

Seniority level

Associate

Employment type

Contract

Job function

Analyst

Industries

Medical Equipment Manufacturing and Pharmaceutical Manufacturing