Quality Assurance Specialist Qualification (m/w/d)

Ihr Profil:

• Master's degree in Engineering, Biotechnology or related field
  
• Minimum of 5 years relevant experience in a GxP regulated pharmaceutical/biotechnology industry
  
• Minimum of 3 years validation and qualification experience required
  
• Solid computer skills including MS Office
  
• Analytical thinking and problem-solving attitude
  
• Ability to work independently
  
• Fluent in German and English, both written and spoken

Ihre Aufgaben:

• Support the implementation of the qualification of equipment/utilities/rooms and computerised system validation (CSV) strategy
  
• Support the transfer from project into commercial production phase
  
• Act as QA representative during qualification of equipment/utilities/rooms and CSV
  
• Ensure compliance of the allocated quality-systems with regulatory expectations
  
• Establish and continuously improve quality procedures within the area of responsibility
  
• Continuously improve the allocated quality systems
  
• Support changes and corrections for the area of responsibility
  
• Participate in audits and inspection within the area of responsibility

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