Quality Assurance Specialist

Start date: Immediately

End date: 30/09/2024/possible extension

Location: Valais, on-site

Key responsibilities:

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• Verification of the company's compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.
  
• Provide immediate support to operations and quality control staff to address compliance related concerns.
  
• Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
  
• Audit internal quality system elements in manufacturing and operational support areas. Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations. Perform external audits of suppliers/vendors/off-site facilities.
  
• Act as a customer interface during on-site audits, conference calls and other standard means of communication. Independently identify and manage special projects or QA compliance functions as agreed upon with QA management. Prioritize and manage a variety of projects simultaneously.
  
• May need to lead and direct the work of others. Review and approve validation documents. Review and Master Batch Records (MBR) and supporting documents. Perform review/release of batch records, as needed.
  

Requirements:

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• 3-5 Years Experience in QA
  
• German language is required
  
• Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.
  
• GMP compliance and Part 11 compliance knowledge preferred.
  
• Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
  
• Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast paced environment; team oriented; independent work skills and a strong work ethic. T
  
• he ability to interface and communicate directly with clients is required. Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.