Specialist QA Compliance
![Travailler chez Bavarian Nordic Berna GmbH Travailler chez Bavarian Nordic Berna GmbH](https://media.jobs.ch/images/d173c7c9-ae8c-4ade-b056-f86bd5031863/banner-2873x958.png?dimensions=1200x400&transform=crop)
![Bavarian Nordic Berna GmbH Bavarian Nordic Berna GmbH](https://media.jobs.ch/images/02dc642d-7d15-472c-95cd-826a6b0ae584/735x370.png)
![Bavarian Nordic Berna GmbH Bavarian Nordic Berna GmbH](https://media.jobs.ch/images/02dc642d-7d15-472c-95cd-826a6b0ae584/735x370.png)
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 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
Specialist QA Compliance 80 - 100% (f/m/d)
Responsible, as QA representative in multidisciplinary teams, to oversee the following topics:
- Deviation, Change Control, CAPA Management, Continuous improvements
- Process Validation
- Product Quality Review (PQR)
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)
- Establishes annual Product Quality Reviews
- 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
- 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
We look forward to receiving your application directly on our recruiting portal!
Lieu de travail
Oberriedstrasse 68
3174 Bern
![Bavarian Nordic Berna GmbH Bavarian Nordic Berna GmbH](https://media.jobs.ch/images/02dc642d-7d15-472c-95cd-826a6b0ae584/735x370.png)
Thörishaus / Bern / Germany or US / Schweiz