Quality Assurance Specialist

QA SPECIALIST 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 Specialist with focus on qualification activities might be the position for you!

We are looking for a candidate that:

• Has a minimum of 5 years of work experience with qualification of equipment for e.g., sterilization, filling, freezing, inspection and packaging within the pharmaceutical and/or biotech industry, preferably within QA
• Holds a relevant Master degree, e.g., engineering
• Has solid GMP/Good Documentation Practice knowledge and familiar with guidelines such as ISPE, EudraLex, PIC/S
• Preferably experience with automation activities, data integrity and validity of systems
• Preferably experience with or at least a keen interest in Environmental Monitoring activities and related equipment such as HVAC
• Master fluent English and Danish in writing and speech

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
• G uidance 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

The QA Operations organization consists of approximately 40 employees, 5 managers and one director based in Kvistgaard and Munich.

It is a growing department which currently consists of these QA teams: Equipment Qualification, Drug Substance, Drug Product, Environment, Quality Control, Raw Material, Warehouse, and the QA Operations Management Team.

You will be part of a well-founded team with 8 colleagues (4 Equipment qualification + 4 Environment) for Equipment qualification 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, Warehouse, Technical Service among other areas.

You will be in Denmark at our site in Kvistgaard.

As a person you are

• Willing and open to make decisions and able to stand firm towards stakeholders
• You have excellent communication skills and a collaborative mindset
• You are detail-oriented and a strong ambassador of a quality mind-set, but also able to apply pragmatic approaches and seeing things from a different angle when needed
• You like to work in a fast paced and changing environment
• Proactive and actively contribute to implementing improvements
• Great sense of accountability and ability to work independently
• Open-minded with a good sense of humor, outgoing and confident attitude

We offer

Besides focusing on saving lives every day – being a large-scale vaccine company, we also offer a great canteen, cold soft drinks, nice coffee, and a modern work environment.

In Bavarian Nordic, we believe in the power of the team, and you will be part of a global team of +1600 dedicated people 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.

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.

The new service improves the commuting experience to and from Kvistgaard, where some of our employees can now benefit from a significant time savings of almost 40 minutes each way, making their daily commute more efficient and convenient.

Do we have your attention? Ready? Set? Apply!

We are interviewing on an ongoing basis and look forward to receiving your application (your CV- it is not mandatory to send us a cover letter) as soon as possible. We cannot wait to get to know you better!

Department:
Hejreskovvej 10A, Kvistgård

Lokation: Denmark