Bavarian Nordic Berna GmbH
Quality Assurance Specialist Qualification(m/w/x)
Full-timeOn-siteExperienced
Bern
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BABavarian Nordic Berna GmbH
QA Specialist – CSV & QV(m/w/x)
Bern
Full-timeOn-siteSenior
Nejo AI Summary
Leading Computer System Validation (CSV) and Qualification/Validation (QV) for mpox, smallpox, and travel vaccines. 5+ years of CSV experience in regulated industries required. Exceptional technology, vibrant work environment.
Requirements
- University degree in engineering, life sciences, computer science, or related field
- Minimum 5 years of experience in CSV and ideally QV within pharmaceutical, biotechnology, or related regulated industry; QA experience is a plus
- Capability to drive and coordinate complex validation projects in cross-functional environment with multiple stakeholders
- In-depth knowledge of cGMP, GAMP, FDA, EMA, and other relevant regulations and guidelines
- Strong technical writing, problem-solving, and project management skills
- Excellent written and spoken English skills; German is an advantage, combined with strong interpersonal and communication abilities
Tasks
- Ensure high quality standards for pharmaceutical products
- Lead Computer System Validation (CSV) activities
- Manage Qualification and Validation (QV) processes
- Comply with regulatory requirements and industry best practices
- Develop CSV and QV strategies, plans, protocols, and reports
- Collaborate with Engineering, Manufacturing, IT, and Quality services
- Participate in audits and inspections for CSV and QV
- Maintain robust documentation for audits and inspections
- Foster a culture of quality and continuous improvement
- Mentor team members and stakeholders
- Support changes and corrections in CSV and QV
- Act as subject matter expert for relevant regulations
- Adhere to EU GMP and FDA 21 CFR Part 11 guidelines
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- CSV
- QV
- cGMP
- GAMP
- FDA
- EMA
Benefits
Modern Equipment
- Exceptional technology
Other Benefits
- Determined team
Startup Environment
- Vibrant and adaptable work environment
Learning & Development
- Support for personal and professional skills growth
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bavarian Nordic Berna 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 Berna GmbH
QA Specialist – CSV & QV(m/w/x)
Bern
Full-timeOn-siteSenior
Nejo AI Summary
Leading Computer System Validation (CSV) and Qualification/Validation (QV) for mpox, smallpox, and travel vaccines. 5+ years of CSV experience in regulated industries required. Exceptional technology, vibrant work environment.
Requirements
- University degree in engineering, life sciences, computer science, or related field
- Minimum 5 years of experience in CSV and ideally QV within pharmaceutical, biotechnology, or related regulated industry; QA experience is a plus
- Capability to drive and coordinate complex validation projects in cross-functional environment with multiple stakeholders
- In-depth knowledge of cGMP, GAMP, FDA, EMA, and other relevant regulations and guidelines
- Strong technical writing, problem-solving, and project management skills
- Excellent written and spoken English skills; German is an advantage, combined with strong interpersonal and communication abilities
Tasks
- Ensure high quality standards for pharmaceutical products
- Lead Computer System Validation (CSV) activities
- Manage Qualification and Validation (QV) processes
- Comply with regulatory requirements and industry best practices
- Develop CSV and QV strategies, plans, protocols, and reports
- Collaborate with Engineering, Manufacturing, IT, and Quality services
- Participate in audits and inspections for CSV and QV
- Maintain robust documentation for audits and inspections
- Foster a culture of quality and continuous improvement
- Mentor team members and stakeholders
- Support changes and corrections in CSV and QV
- Act as subject matter expert for relevant regulations
- Adhere to EU GMP and FDA 21 CFR Part 11 guidelines
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- CSV
- QV
- cGMP
- GAMP
- FDA
- EMA
Benefits
Modern Equipment
- Exceptional technology
Other Benefits
- Determined team
Startup Environment
- Vibrant and adaptable work environment
Learning & Development
- Support for personal and professional skills growth
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bavarian Nordic Berna 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 Berna 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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