Lonza
Senior QA Specialist/QA Project Manager(m/w/x)
Full-timeOn-siteSenior
Visp
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Managing QA operations during commissioning and qualification for biopharmaceutical manufacturing projects, reviewing Master Batch Records. Significant biopharmaceutical manufacturing QA experience with strong cGMP background required. Relocation assistance, performance-based compensation programs.
Requirements
- Academic degree in Biotechnology, Biochemistry, or related field
- Significant experience in biopharmaceutical manufacturing, preferably in QA
- Strong background in cGMP and biotechnological manufacturing processes
- Sound experience in representing Quality and Compliance in projects
- Good communication skills and experience in interaction with interfaces
- Experience in TrackWise, LIMS, DMS, and SAP preferred
- Excellent written and spoken English; knowledge of German advantageous
Tasks
- Coordinate QA interests during project phases
- Manage project-specific QA operations during commissioning and qualification
- Review and release Standard Operating Procedures (SOPs)
- Finalize Master Manufacturing Batch Records
- Assess Material Specifications and Quality Risk Assessments
- Handle deviations, CAPAs, and change requests
- Conduct effectiveness checks and testing protocols
- Independently manage stakeholder needs in a customer-focused environment
- Participate in regulatory inspections and customer audits
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- TrackWise
- LIMS
- DMS
- SAP
Benefits
Bonuses & Incentives
- Compensation programs for high performance
Career Advancement
- Agile career
Startup Environment
- Dynamic working culture
Purpose-Driven Work
- Inclusive and ethical workplace
Other Benefits
- Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CH12 Lonza AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Managing QA operations during commissioning and qualification for biopharmaceutical manufacturing projects, reviewing Master Batch Records. Significant biopharmaceutical manufacturing QA experience with strong cGMP background required. Relocation assistance, performance-based compensation programs.
Requirements
- Academic degree in Biotechnology, Biochemistry, or related field
- Significant experience in biopharmaceutical manufacturing, preferably in QA
- Strong background in cGMP and biotechnological manufacturing processes
- Sound experience in representing Quality and Compliance in projects
- Good communication skills and experience in interaction with interfaces
- Experience in TrackWise, LIMS, DMS, and SAP preferred
- Excellent written and spoken English; knowledge of German advantageous
Tasks
- Coordinate QA interests during project phases
- Manage project-specific QA operations during commissioning and qualification
- Review and release Standard Operating Procedures (SOPs)
- Finalize Master Manufacturing Batch Records
- Assess Material Specifications and Quality Risk Assessments
- Handle deviations, CAPAs, and change requests
- Conduct effectiveness checks and testing protocols
- Independently manage stakeholder needs in a customer-focused environment
- Participate in regulatory inspections and customer audits
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- TrackWise
- LIMS
- DMS
- SAP
Benefits
Bonuses & Incentives
- Compensation programs for high performance
Career Advancement
- Agile career
Startup Environment
- Dynamic working culture
Purpose-Driven Work
- Inclusive and ethical workplace
Other Benefits
- Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CH12 Lonza AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
CH12 Lonza AG
Industry
Pharmaceuticals
Description
The company is a global leader in life sciences, dedicated to improving lives through innovative solutions.
Not a perfect match?
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