Bavarian Nordic Berna GmbH
Quality Assurance Specialist Qualification(m/w/x)
Full-timeOn-siteExperienced
Bern
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BABavarian Nordic GmbH
QA Sterility Assurance Specialist(m/w/x)
Bern
Full-timeOn-siteSenior
Nejo AI Summary
Contamination control and risk assessments for aseptic processing in vaccine manufacturing. 5 years GMP biologics/sterile manufacturing, 2+ years QA aseptic leadership required. Direct impact on global health initiatives.
Requirements
- Bachelor’s or Master’s degree in Microbiology, Biology, Pharmacy, or related scientific field
- Minimum 5 years’ experience in GMP biologics or sterile manufacturing, including 2+ years in QA sterility/aseptic leadership
- Strong background in sterility assurance or quality management within GMP-regulated environments
- Demonstrated experience in investigations, CAPA, risk management, and audit interactions
- Excellent communication, collaboration, and decision-making skills under time-sensitive conditions
- Analytical, detail-oriented, and skilled in risk-based problem solving with a continuous improvement mindset
- Full professional proficiency in English; basic German is an advantage
- Proactive problem-solver with strong communication skills
Tasks
- Develop and maintain sterility assurance strategies
- Establish contamination control strategies for aseptic processing
- Lead risk assessments for aseptic processes and critical interventions
- Ensure compliance with relevant authorities' guidance
- Manage deviations and conduct root cause analyses for sterility issues
- Implement CAPA and efficiency checks for bioburden and endotoxin
- Provide training on aseptic and sterility best practices
- Mentor operations and QA staff to promote contamination control culture
- Stay updated on regulatory developments and revise procedures as needed
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bavarian Nordic GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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BABavarian Nordic GmbH
QA Sterility Assurance Specialist(m/w/x)
Bern
Full-timeOn-siteSenior
Nejo AI Summary
Contamination control and risk assessments for aseptic processing in vaccine manufacturing. 5 years GMP biologics/sterile manufacturing, 2+ years QA aseptic leadership required. Direct impact on global health initiatives.
Requirements
- Bachelor’s or Master’s degree in Microbiology, Biology, Pharmacy, or related scientific field
- Minimum 5 years’ experience in GMP biologics or sterile manufacturing, including 2+ years in QA sterility/aseptic leadership
- Strong background in sterility assurance or quality management within GMP-regulated environments
- Demonstrated experience in investigations, CAPA, risk management, and audit interactions
- Excellent communication, collaboration, and decision-making skills under time-sensitive conditions
- Analytical, detail-oriented, and skilled in risk-based problem solving with a continuous improvement mindset
- Full professional proficiency in English; basic German is an advantage
- Proactive problem-solver with strong communication skills
Tasks
- Develop and maintain sterility assurance strategies
- Establish contamination control strategies for aseptic processing
- Lead risk assessments for aseptic processes and critical interventions
- Ensure compliance with relevant authorities' guidance
- Manage deviations and conduct root cause analyses for sterility issues
- Implement CAPA and efficiency checks for bioburden and endotoxin
- Provide training on aseptic and sterility best practices
- Mentor operations and QA staff to promote contamination control culture
- Stay updated on regulatory developments and revise procedures as needed
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bavarian Nordic GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Bavarian Nordic GmbH
Industry
Pharmaceuticals
Description
The company is a global leader in developing life-saving vaccines with over 30 years of experience.
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