Quality Assurance Associate – Biotherapeutics (1 Year Contract)

About the role

A specialist biotherapeutics manufacturer with over a century of experience in treating coagulation disorders, immunological diseases, enzyme deficiency diseases and other rare diseases is looking for a Quality Assurance Associate for its headquarters in Bern. The position is initially a 1-year contract, with the possibility of extension. The role supports aseptic manufacturing and microbiological laboratories without performing activities inside them.

Key responsibilities

• Support and consult on aseptic manufacturing and microbiological laboratories, and review and ensure compliance with GMP requirements in production
• Control, review and document work steps and processes in aseptic production
• Take part in the training and (re)qualification of aseptic production employees
• Support investigations of deviations in aseptic filling: initial assessments, investigation strategy, CAPA definition, and review of investigation reports in German and English
• Participate in preparing deviations for internal and external inspections
• Support the review of specification documents

Required profile

• Swiss working/residency permit and/or Swiss or EU citizenship
• Degree in a scientific field (Master, PhD)
• Several years of QA experience in a pharmaceutical company and GMP environment
• Experience with deviation management, change management and quality on the floor
• Experience working with a QMS
• Native-level German and professional English, spoken and written
• Willingness to travel to Bern (no more than 1 hour)

Required skills

• GMP compliance and quality assurance
• Deviation management and CAPA
• QMS