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Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)
Overseeing facility and utility qualification in biopharmaceutical production. Degree in life sciences or engineering with significant biopharmaceutical manufacturing and cGMP experience required. Hybrid work model.
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
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
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- cGMP
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
Not a perfect match?
- CH12 Lonza AGFull-timeOn-siteSeniorVisp
- Lonza
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Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)
Overseeing facility and utility qualification in biopharmaceutical production. Degree in life sciences or engineering with significant biopharmaceutical manufacturing and cGMP experience required. Hybrid work model.
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
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
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- cGMP
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.
Not a perfect match?
- CH12 Lonza AG
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