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Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)
Description
In this role, you will ensure facility and equipment compliance with cGMP standards while acting as a key quality representative in technical projects to drive continuous improvement and audit readiness.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Degree in Biotechnology, Pharmacy, Microbiology, Chemistry, Engineering or related field
- •Significant experience in biopharmaceutical manufacturing and cGMP background
- •Broad knowledge of engineering and manufacturing processes
- •Good communication and interaction skills with organizational interfaces
- •Sound experience representing Quality and Compliance in projects
- •Strong team orientation
- •Fluency in English, German would be an asset
Education
Tasks
- •Ensure facility and equipment qualification complies with cGMP
- •Represent Quality and Compliance in cross-functional project teams
- •Oversee qualification and routine monitoring of utilities
- •Coordinate quality objectives across various project phases
- •Identify and integrate emerging QA technologies into standards
- •Review and approve qualification plans and reports
- •Assess technical change requests for qualification relevance
- •Document and investigate project deviations and issues
- •Drive CAPA and effectiveness checks to timely completion
- •Represent environmental monitoring topics during audits and inspections
- •Write and revise SOPs as a subject matter expert
Tools & Technologies
Languages
English – Business Fluent
German – Basic
Benefits
Bonuses & Incentives
- •Performance-based compensation programs
Family Support
- •Lifestyle, family, and leisure benefits
Career Advancement
- •Agile career
Informal Culture
- •Dynamic work culture
Purpose-Driven Work
- •Inclusive and ethical workplace
Other Benefits
- •Relocation assistance
- CH12 Lonza AGFull-timeOn-siteSeniorVisp
- Lonza
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Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)
The AI Job Search Engine
Description
In this role, you will ensure facility and equipment compliance with cGMP standards while acting as a key quality representative in technical projects to drive continuous improvement and audit readiness.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
Requirements
- •Degree in Biotechnology, Pharmacy, Microbiology, Chemistry, Engineering or related field
- •Significant experience in biopharmaceutical manufacturing and cGMP background
- •Broad knowledge of engineering and manufacturing processes
- •Good communication and interaction skills with organizational interfaces
- •Sound experience representing Quality and Compliance in projects
- •Strong team orientation
- •Fluency in English, German would be an asset
Education
Tasks
- •Ensure facility and equipment qualification complies with cGMP
- •Represent Quality and Compliance in cross-functional project teams
- •Oversee qualification and routine monitoring of utilities
- •Coordinate quality objectives across various project phases
- •Identify and integrate emerging QA technologies into standards
- •Review and approve qualification plans and reports
- •Assess technical change requests for qualification relevance
- •Document and investigate project deviations and issues
- •Drive CAPA and effectiveness checks to timely completion
- •Represent environmental monitoring topics during audits and inspections
- •Write and revise SOPs as a subject matter expert
Tools & Technologies
Languages
English – Business Fluent
German – Basic
Benefits
Bonuses & Incentives
- •Performance-based compensation programs
Family Support
- •Lifestyle, family, and leisure benefits
Career Advancement
- •Agile career
Informal Culture
- •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.
- CH12 Lonza AG
Senior QA Specialist(m/w/x)
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