Specialist QA Compliance and Sterility Assurance 80 - 100% (f/m/d)

For us, it is all about improving and saving lives

We are a fully integrated vaccine company focused on the development, manufacturing, and commercialization of vaccines, and our vision is to become one of the largest pure-play vaccine companies in the world. At Bavarian Nordic, you will be part of a global team of +1600 dedicated colleagues worldwide, all passionate about making a difference. We offer an inclusive and flexible workplace with a strong focus on personal and professional development, and we welcome people who are passionate about saving lives. If you are open-minded and have the willpower to succeed, we might just be a perfect fit.

At Bavarian Nordic Berna, the Swiss affiliate there are - beside manufacturing activities – professionals in Quality Assurance, Quality Control, Supply Chain and Regulatory affairs working. On the Swiss site of Bavarian Nordic in Thörishaus / Bern there are approx. 160 dedicated and committed professionals working locally and globally.

To complement and strengthen our Quality Assurance Team we are looking for a

as QA representative in multidisciplinary teams, to oversee the following topics:

• Deviation, Change Control, CAPA Management
• Sterility Assurance and Contamination Control
• Process Validation

 What is in the role for you:

• Reviews and approves deviations, investigations, CAPAs and Change Controls
• Reviews and approves process validation documents including risk assessments
• Oversees site manufacturing activities (oral and parenteral) concerning sterility assurance
• Owns the Contamination Control Strategy documents of the site
• Establishes annual Product Quality Reviews
• Establishes and approves trend reports
• Ensures regulatory compliance and continuously improves the allocated quality systems and procedures
• Participates in audits and inspection within the area of responsibility

What do you bring to it:

• Master’s degree preferrably in Life Sciences or related field with track record in Microbiology and Sterility Assurance
• Minimum of 5 years relevant experience in a GxP regulated pharmaceutical/biotechnology industry

• Solid computer skills including MS Office required / SAP, LIMS, Quality Management Systems skills are a plus
• Analytical thinking and problem-solving attitude
• Multilingual – at least German and English, written and spoken

We provide an opportunity to be a part of an international company that boasts exceptional technology and a determined team. Join our dedicated and agile QA team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and academic skills.