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Senior QA Expert - Equipment Qualification & Validation(m/w/x)
Leading qualification of aseptic fill and finish equipment, managing GMP deviations at global life sciences firm. Experience with aseptic fill&finish lines and health authority audits required. Relocation assistance available.
Requirements
- Experience with aseptic fill&finish lines
- Experience with equipment qualification and validation
- Experience with health authority audits
- Degree in life science or equivalent
- Teamwork and positive culture contribution
- Experience or interest in data integrity
- Fluency in English and German skills
Tasks
- Lead qualification and validation for aseptic fill and finish equipment
- Manage GMP deviations within global quality management systems
- Define qualification strategies for CAPEX and OPEX projects
- Supervise equipment trending and sterilization process validation
- Oversee change control management and CAPA handling
- Serve as subject matter expert during audits and inspections
- Manage the lifecycle of equipment qualification documentation
- Approve SOPs, qualification protocols, and technical reports
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- aseptic fill&finish lines
- GMP
- Swissmedic
- FDA
- data integrity (DI)
Benefits
Bonuses & Incentives
- Performance-based compensation programs
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Other Benefits
- Relocation assistance
Learning & Development
- Agile career opportunities
Startup Environment
- Dynamic work culture
Purpose-Driven Work
- Inclusive and ethical workplace
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Senior QA Expert - Equipment Qualification & Validation(m/w/x)
Leading qualification of aseptic fill and finish equipment, managing GMP deviations at global life sciences firm. Experience with aseptic fill&finish lines and health authority audits required. Relocation assistance available.
Requirements
- Experience with aseptic fill&finish lines
- Experience with equipment qualification and validation
- Experience with health authority audits
- Degree in life science or equivalent
- Teamwork and positive culture contribution
- Experience or interest in data integrity
- Fluency in English and German skills
Tasks
- Lead qualification and validation for aseptic fill and finish equipment
- Manage GMP deviations within global quality management systems
- Define qualification strategies for CAPEX and OPEX projects
- Supervise equipment trending and sterilization process validation
- Oversee change control management and CAPA handling
- Serve as subject matter expert during audits and inspections
- Manage the lifecycle of equipment qualification documentation
- Approve SOPs, qualification protocols, and technical reports
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- aseptic fill&finish lines
- GMP
- Swissmedic
- FDA
- data integrity (DI)
Benefits
Bonuses & Incentives
- Performance-based compensation programs
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Other Benefits
- Relocation assistance
Learning & Development
- Agile career opportunities
Startup Environment
- Dynamic work culture
Purpose-Driven Work
- Inclusive and ethical workplace
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.
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