QA CSV & Qualification for Laboratory Equipment

• Controls, approves/releases computerized system validation documents by following regulatory guidelines and local operating procedures
  

• Controls, approves/releases qualification documents by following regulatory guidelines and local operating procedures
  

• Approves/releases equipment related Deviations
  

• Ensures c GMP compliance
  

• Supports the business through ongoing change and process improvement activities.
  

• Bachelor or Master degree in IT, chemistry, biotechnology, life science or related field.
  

• Previous experience in Deviations and c GMP in a regulated pharmaceutical/API industry is a strong advantage.
  

• Knowledge of biotech. manufacturing processes and analytical methods is an advantage.
  

• Experience with Human and Organizational Performance & risk management approaches is an advantage
  

• Fluency in German, both written and spoken. English is an advantage.
  

• Technical writing & presentation/communication skills are key for the role. Demonstrated previous experience is a strong advantage.
  

• Structured, focused and well-organised working attitude. Open-minded for new ideas and suggestions; agile, highly motivated and dynamically driven.
  

• Ability to work with and lead a team of SMEs without formal authority, as well as to deliver projects working independently.