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Senior QA Expert – Critical Utilities & Facilities(m/w/x)
Leading qualification and validation for critical utilities and facilities at a global life sciences manufacturer, managing GMP deviations. Experience with health authority audits and GMP regulatory guidelines essential. Global project scope, hybrid work model.
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 Fluent
- German – Basic
Tools & Technologies
- GMP Annex 1
- GMP Annex 11
- GMP Annex 15
- HVAC
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
Not a perfect match?
- LonzaFull-timeOn-siteSeniorStein (AR)
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Senior QA Expert – Critical Utilities & Facilities(m/w/x)
Leading qualification and validation for critical utilities and facilities at a global life sciences manufacturer, managing GMP deviations. Experience with health authority audits and GMP regulatory guidelines essential. Global project scope, hybrid work model.
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 Fluent
- German – Basic
Tools & Technologies
- GMP Annex 1
- GMP Annex 11
- GMP Annex 15
- HVAC
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
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)
Full-timeOn-siteSeniorStein (AR) - Lonza
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Full-timeOn-siteSeniorStein (AR) - Lonza
QA Expert - Equipment Qualification & Validation and Data Integrity(m/w/x)
Full-timeOn-siteExperiencedStein (AR) - Lonza
HVAC & Utilities Engineer DPS Growth Project(m/w/x)
Full-timeOn-siteExperiencedStein (AR) - CH12 Lonza AG
Global MSAT Drug Product Qualification and Validation Lead(m/w/x)
Full-timeOn-siteSeniorStein (AR)