QA SENIOR PROFESSIONAL FOR QUALIFICATION OF GXP MANUFACTURING EQUIPMENT, FACILITIES AND UTILITY SYSTEMS
Would you like to be part of a strong and very skilled QA team supporting the qualification of GxP manufacturing equipment, facilities and utility systems?
Are you motivated by a diverse everyday life characterized by new challenges and problem solving?
Then a position as QA Senior Professional with focus on qualification activities might be the position for you!
We are looking for a candidate that:
Has a minimum of 2-3 years work experience with qualification of equipment for e.g., sterilization, filling, freezing, inspection and packaging within the life science industry, preferably within QA
Has solid GMP and GDocP knowledge
Is familiar with guidelines such as ISPE, EudraLex, PIC/S
Has preferably experience with automation activities
Master English and understand Danish in writing and reading
The role as QA for Equipment qualification
QA Review and approve validation on behalf of the Line of Business (VPL, URS, XQPs, …)
QA Review and approve SOPs, Change Controls, Deviations and CAPAs
Guidance during root cause analysis
Improve the BN Quality Management system (QMS)
Daily collaboration and prioritization
Provide qualitative advice and ensure quality oversight & compliance
Participation in optimization projects within daily operations
Boost our team
You will be part of a well-founded team with 9 colleagues (4 EQ + 5 EM) in QA Operations reporting to the QA Ops Manager for Qualification and Environment.
You will work in close collaboration with a broad range of stakeholders, including Manufacturing, Facilities, Warehouse, Technical Service among other areas.
As a person you are
Decisive and confident in managing stakeholders and making key decisions.
Excellent communication skills with a collaborative and open-minded approach.
Detail-oriented and quality-focused, but flexible and pragmatic when needed.
Thrives in fast-paced, dynamic environments and proactively drives improvements.
Independent, accountable, and able to oversee larger project responsibilities.
Our employees also have the advantage of being able to use our bus route, 70E, which runs from Humlebæk Station directly to our production facilities in Kvistgaard. The bus has four departures every morning and afternoon with scheduled stops at Hørsholmvej and Kvistgaard St.
For us, it is all about improving and saving lives
Improving and saving lives through innovative vaccines is at the heart of what we do in Bavarian Nordic. We are a fully integrated vaccine company focused on the development, manufacturing, and commercialization of life-saving vaccines, and one of the largest pure-play vaccine companies in the world.
In Bavarian Nordic, we believe in the power of the team, and you will be part of a global team of more than +1600 dedicated employees with diverse backgrounds and viewpoints, who are bound together by our commitment to protect lives every day. We believe in creating an inclusive and flexible workplace with a strong focus on personal and professional development because we need each other to take things further.
Ready to make a Difference? Apply Now!
Apply by clicking the ‘APPLY’ button. We are interviewing on an ongoing basis and look forward to receiving your motivated CV as soon as possible. It is not mandatory to send a cover letter. Applications submitted via email will not be considered.
Location: Kvistgaard - Hejreskovvej 18