Quality Assurance Associate (7155)

Quality Assurance Associate

Join a specialist biotherapeutics manufacturer with over a century of experience in treating various diseases worldwide. This organization is dedicated to supporting patients with coagulation disorders, immunological diseases, enzyme deficiency diseases, and other rare conditions. As a Quality Assurance Associate, you will play a pivotal role in ensuring compliance and quality within their aseptic manufacturing processes.

Key Responsibilities

• Provide support and consulting services for aseptic manufacturing and microbiological laboratories, focusing on process review rather than direct performance of manufacturing or laboratory activities.
• Review and ensure strict compliance with GMP requirements in production environments.
• Control, review, and document work steps, including the review of processes in aseptic production.
• Participate in the training and (re)qualification of aseptic production employees.
• Support deviation management in the area of aseptic filling by conducting initial assessments and supporting the definition of investigation strategies, including the evaluation of technical assessments.
• Assist the operations group in deviation investigations, including the definition of appropriate corrective and preventive actions (CAPAs) to prevent recurrence.
• Review investigation reports in German and English, assessing them for compliance and risk.
• Participate in the preparation of deviations for internal and external inspections.
• Support in the review of specification documents.

Qualifications and Experience

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship.
• Degree in a scientific field (Master, PhD).
• Several years of QA experience within a pharmaceutical company and GMP environment.
• Experience with deviation management, change management, and quality on the floor.
• Experience working with QMS.
• Strong enthusiasm, analytical thinking, and effective communication skills.
• Precise and reliable work approach with the ability to prioritize effectively.
• Flexibility and ability to work independently as well as in a team, maintaining composure in fast-paced environments.
• Willingness to travel to Bern (no longer than 1 hour).
• Native level of German and professional English, both spoken and written.