Title: Quality Assurance Associate
Location: Bern, Switzerland
Duration: 12 months
Job Description:

• Support and consultation in the area of aseptic manufacturing and microbiological laboratories (no direct execution of activities within manufacturing or the laboratory)

• Reviewing and ensuring compliance with GMP requirements in production

• Monitoring, reviewing, and documenting work steps; process review in aseptic production

• Participation in the training and (re)qualification of employees in aseptic production

• Handling deviations in the area of aseptic filling:

  • Performing initial assessments

  • Providing support in defining the investigation strategy, including evaluation of technical assessments as part of the investigation

  • Supporting the operations team in deviation investigations, including defining appropriate corrective and preventive actions (CAPAs) to prevent recurrence of similar deviations

  • Reviewing investigation reports in both German and English, and assessing them in terms of compliance and risk evaluation

• Assisting in the preparation of deviations for internal and external inspections

• Support in reviewing procedural documents