We are looking for German-speaking Quality Assurance oriented people to work at one of our Bern clients in the pharmaceutical industry.
About the Client
Our client is a global leader in the development of biopharmaceutical therapies, with a key manufacturing site in Bern, Switzerland. Known for their expertise in rare-disease therapies, the company offers a high-performing environment where compliance, quality, and innovation drive every aspect of production.
Job Description
This role is focused on ensuring regulatory compliance within aseptic manufacturing operations. The position involves reviewing production processes, supporting investigations of deviations, and helping implement corrective actions to uphold GMP standards. You will also contribute to training initiatives and internal audit preparation. Strong documentation skills and a detail-oriented approach are essential to success in this role.
Responsibilities
- Oversee and verify GMP compliance in sterile production environments
- Review and document aseptic manufacturing steps and processes
- Support investigations into deviations, including initial assessments and root cause analysis
- Collaborate on the development and implementation of corrective and preventive actions (CAPAs)
- Evaluate and approve technical reports and compliance-related documentation in German and English
- Assist in preparing for internal and external audits or inspections
- Participate in the training and qualification of production staff
- Contribute to the maintenance and improvement of specification documents
Requirements
- Degree in life sciences, biotechnology, pharmacy, or a related field.
- Minimum 1 year experience in aseptic production or pharmaceutical quality assurance.
- Fluency in German.
- Strong understanding of GMP and compliance requirements.
- Ability to assess and document technical processes and deviations.
- Familiarity with CAPA processes and risk-based decision-making.
- Detail-oriented mindset with strong documentation habits.
- Experience supporting audits or regulatory inspections is a plus.
