QA Specialist for Environmental Support

In this role, you will join Bavarian Nordic's QA Organization as a QA Specialist tasked with establishing strong relationships with stakeholders, effectively communicating GxP requirements, and handling crucial Quality Events in the Quality Management System (QMS). This is in the context of environmental monitoring, aseptic performance, and sterile & low bioburden processes in Drug Substance and Drug Product Production. Additionally, you will contribute to the ongoing improvement of QA processes to elevate overall quality standards.

Boost our team
Our QA Operations department comprises currently approximately 36 dedicated professionals based in Kvistgaard and Munich, along with one director and three managers. The department includes various QA teams: Drug Substance, Drug Product, Equipment Qualification, Environment, QC, RM, and Warehouse. You will become a part of the QA for Environment team, working alongside two experienced QA specialists and two QA professionals, and reporting to the QA Manager for the Qualification and Environment team. In this team, we care a lot about good team spirit and cooperation. We also promote a quality mindset throughout the organization.

You will be part of a global and fully integrated vaccine company committed to improving and saving lives through innovative vaccines.

This is how you impact the people we are here to serve
Our vaccines make a real difference to people, and no matter your role we all contribute to protecting lives every day. This is how your work matters:

• Reviewing and approving SOPs, Change Controls, Deviations, CAPAs, and Continuous Improvements
• Supporting and approving (re)qualifications of HVAC, VHP, Clean Utility, and more
• QA Oversight and housekeeping in Drug Substance and Drug Product Production areas Grade A-D and CNC
• Reviewing and approving strategies, risk assessments, and trend reports for controlling and monitoring the Environment and Clean Utility
• Participating in projects related to rebuilding, shutdown activities, improving Drug Substance and Drug Product production processes, and ensuring regulatory compliance.

Are you our next pioneer?
Succeeding with our vision of becoming one of the largest pure-play vaccine companies in the world is no walk in the park, and that is why we need people like you who are determined to make it happen and have the following qualifications:

• A relevant master’s degree in pharmacology, Biochemistry, Microbiology, Virology, or a similar field
• A minimum of 5 years of experience in a similar QA position
• Fluency in English and/or Danish
• Experience with Quality Risk Management and Systematic Problem Solving
• Knowledge of GMP and aseptic work

Who are you?
We're looking for a robust profile who excels in a challenging environment that requires a strong commitment to maintaining high-quality standards. Your ability to appreciate and actively engage in team discussions is an asset. Furthermore, you should have a great sense of accountability and the ability to work independently.

For us, it is all about improving and saving lives
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 share our passion for saving lives. If you are open-minded and have the willpower to succeed, we might just be a perfect fit for you.

Do we have your attention? Does this sound like something for you? Ready - Set - Apply!
We are interviewing on an ongoing basis and look forward to receiving your CV. It is not mandatory to send us a motivating application/cover letter. We cannot wait to get to know you better!

Please contact Guillaume Pauwels, QA Manager for Qualification and Environment via +45 21653385 if you have any questions.

Department:
Hejreskovvej 10A, Kvistgård

Application deadline: 04 Aug 2024