Quality Assurance Specialist

at  Bavarian Nordic

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

• 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