Lonza
Senior QA Expert - Equipment Qualification & Validation(m/w/x)
Full-timeOn-siteSenior
Stein (AR)
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LOLonza
Senior QA Expert – Critical Utilities & Facilities(m/w/x)
Stein (AR)
Full-timeOn-siteSenior
Nejo AI Summary
You will lead the qualification of critical utilities for sterile manufacturing, ensuring GMP compliance across high-impact projects while acting as a key expert during audits and inspections.
Requirements
- Experience in qualification and validation
- Experience with health authority audits
- Knowledge of GMP regulatory guidelines
- Degree in life science or equivalent
- Teamwork and support of colleagues
- Fluency in English and German skills
Tasks
- Lead qualification and validation for infrastructure and utilities
- Manage GMP deviations within global QMS systems
- Define qualification strategies for CAPEX and OPEX projects
- Supervise change control, deviations, and CAPA handling
- Monitor GMP status and trending for re-qualification
- Serve as SME during audits and inspections
- Approve SOPs, qualification protocols, and reports
- Oversee lifecycle management for qualification documents
Work Experience
approx. 4 - 6 years
Education
Bachelor's degree
Languages
English – Business FluentGerman – Basic
Tools & Technologies
GMP Annex 1GMP Annex 11GMP Annex 15HVAC
Benefits
Bonuses & Incentives
- •Performance-based compensation programs
Corporate Discounts
- •Lifestyle benefits
- •Leisure benefits
Family Support
- •Family benefits
Career Advancement
- •Agile career
Startup Environment
- •Dynamic work culture
Purpose-Driven Work
- •Inclusive and ethical workplace
Other Benefits
- •Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza 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.
Not a perfect match?
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LOLonza
Senior QA Expert – Critical Utilities & Facilities(m/w/x)
Stein (AR)
Full-timeOn-siteSenior
Nejo AI Summary
You will lead the qualification of critical utilities for sterile manufacturing, ensuring GMP compliance across high-impact projects while acting as a key expert during audits and inspections.
Requirements
- Experience in qualification and validation
- Experience with health authority audits
- Knowledge of GMP regulatory guidelines
- Degree in life science or equivalent
- Teamwork and support of colleagues
- Fluency in English and German skills
Tasks
- Lead qualification and validation for infrastructure and utilities
- Manage GMP deviations within global QMS systems
- Define qualification strategies for CAPEX and OPEX projects
- Supervise change control, deviations, and CAPA handling
- Monitor GMP status and trending for re-qualification
- Serve as SME during audits and inspections
- Approve SOPs, qualification protocols, and reports
- Oversee lifecycle management for qualification documents
Work Experience
approx. 4 - 6 years
Education
Bachelor's degree
Languages
English – Business FluentGerman – Basic
Tools & Technologies
GMP Annex 1GMP Annex 11GMP Annex 15HVAC
Benefits
Bonuses & Incentives
- •Performance-based compensation programs
Corporate Discounts
- •Lifestyle benefits
- •Leisure benefits
Family Support
- •Family benefits
Career Advancement
- •Agile career
Startup Environment
- •Dynamic work culture
Purpose-Driven Work
- •Inclusive and ethical workplace
Other Benefits
- •Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza 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
Lonza
Industry
Pharmaceuticals
Description
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
Not a perfect match?
- Lonza
Senior QA Expert - Equipment Qualification & Validation(m/w/x)
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