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Head of QA Support (Shop Floor and Batch Record Review)(m/w/x)
Oversight of QA Documentation and Shop Floor teams, reviewing Aseptic Processing Simulations for Drug Product manufacturing at a global biopharmaceutical manufacturer. Extensive Drug Product QA and people leadership experience essential. Leading QA teams across multiple global manufacturing sites.
Requirements
- University degree in Chemistry, Biology, Biotechnology, or related field
- Experience in people leadership and strategic roles
- Valuable experience in QA department specifically Drug Product
- Fluent English language skills
- Advantageous German language skills
Tasks
- Oversee the QA Documentation and Shop Floor teams
- Implement and execute the QA Oversight program
- Monitor routine manufacturing and testing activities
- Review and approve Aseptic Processing Simulations
- Develop APS strategies, annual plans, and protocols
- Perform batch record reviews for paper and MES
- Represent QA during MES implementation projects
- Manage the archiving of paper and digital documents
- Lead Deviation Review Board meetings
- Provide GXP-related training to operations personnel
- Author and approve GMP-relevant documents and SOPs
- Support continuous improvement of the Quality Management System
- Prepare batch release documentation for the responsible person
- Coordinate with customers regarding QA operations topics
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Benefits
Bonuses & Incentives
- Performance-based compensation programs
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Career Advancement
- Agile career
Informal Culture
- Dynamic work culture
Purpose-Driven Work
- Inclusive and ethical workplace
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- LonzaFull-timeOn-siteSeniorVisp
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Head of QA Support (Shop Floor and Batch Record Review)(m/w/x)
Oversight of QA Documentation and Shop Floor teams, reviewing Aseptic Processing Simulations for Drug Product manufacturing at a global biopharmaceutical manufacturer. Extensive Drug Product QA and people leadership experience essential. Leading QA teams across multiple global manufacturing sites.
Requirements
- University degree in Chemistry, Biology, Biotechnology, or related field
- Experience in people leadership and strategic roles
- Valuable experience in QA department specifically Drug Product
- Fluent English language skills
- Advantageous German language skills
Tasks
- Oversee the QA Documentation and Shop Floor teams
- Implement and execute the QA Oversight program
- Monitor routine manufacturing and testing activities
- Review and approve Aseptic Processing Simulations
- Develop APS strategies, annual plans, and protocols
- Perform batch record reviews for paper and MES
- Represent QA during MES implementation projects
- Manage the archiving of paper and digital documents
- Lead Deviation Review Board meetings
- Provide GXP-related training to operations personnel
- Author and approve GMP-relevant documents and SOPs
- Support continuous improvement of the Quality Management System
- Prepare batch release documentation for the responsible person
- Coordinate with customers regarding QA operations topics
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Benefits
Bonuses & Incentives
- Performance-based compensation programs
Corporate Discounts
- Lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Career Advancement
- Agile career
Informal Culture
- 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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