CH12 Lonza AG
Senior QA Specialist(m/w/x)
Full-timeOn-siteSenior
Visp
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LOLonza
Senior QA Specialist/QA Project Manager(m/w/x)
Visp
Full-timeOn-siteSenior
Nejo AI Summary
Representing Quality and Compliance in cross-functional teams for biopharmaceutical supply manufacturing, defining quality requirements. Experience representing Quality and Compliance in biopharmaceutical manufacturing, with cGMP background required. Work in cross-functional teams.
Requirements
- Degree in Biotechnology, Biology, or Chemistry
- Experience in biopharmaceutical manufacturing or QA
- Background in cGMP and biotechnological processes
- Experience representing Quality and Compliance
- Communication skills and regulatory agency interaction
- Preferred experience with TrackWise, LIMS, DMS, SAP
- Excellent English and advantageous German knowledge
Tasks
- Define quality requirements for manufacturing processes
- Ensure compliance with cGMP standards and regulations
- Represent Quality and Compliance in cross-functional teams
- Provide full QA oversight for specific products
- Manage manufacturing activities for commercial biopharmaceutical supply
- Represent QA during new biotech tech transfers
- Coordinate QA interests throughout various project phases
- Make quality decisions in internal and external meetings
- Review and release SOPs and batch records
- Approve material specifications and quality risk assessments
- Manage deviations, CAPAs, and change requests
- Assess product changes for regulatory filing relevance
- Support investigations into customer product complaints
- Develop new quality and compliance strategies
- Generate annual product quality reviews
- Support 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
- Performance-based compensation programs
Career Advancement
- Agile career
Informal Culture
- Dynamic working culture
Purpose-Driven Work
- Inclusive and ethical workplace
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza 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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LOLonza
Senior QA Specialist/QA Project Manager(m/w/x)
Visp
Full-timeOn-siteSenior
Nejo AI Summary
Representing Quality and Compliance in cross-functional teams for biopharmaceutical supply manufacturing, defining quality requirements. Experience representing Quality and Compliance in biopharmaceutical manufacturing, with cGMP background required. Work in cross-functional teams.
Requirements
- Degree in Biotechnology, Biology, or Chemistry
- Experience in biopharmaceutical manufacturing or QA
- Background in cGMP and biotechnological processes
- Experience representing Quality and Compliance
- Communication skills and regulatory agency interaction
- Preferred experience with TrackWise, LIMS, DMS, SAP
- Excellent English and advantageous German knowledge
Tasks
- Define quality requirements for manufacturing processes
- Ensure compliance with cGMP standards and regulations
- Represent Quality and Compliance in cross-functional teams
- Provide full QA oversight for specific products
- Manage manufacturing activities for commercial biopharmaceutical supply
- Represent QA during new biotech tech transfers
- Coordinate QA interests throughout various project phases
- Make quality decisions in internal and external meetings
- Review and release SOPs and batch records
- Approve material specifications and quality risk assessments
- Manage deviations, CAPAs, and change requests
- Assess product changes for regulatory filing relevance
- Support investigations into customer product complaints
- Develop new quality and compliance strategies
- Generate annual product quality reviews
- Support 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
- Performance-based compensation programs
Career Advancement
- Agile career
Informal Culture
- Dynamic working culture
Purpose-Driven Work
- Inclusive and ethical workplace
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Lonza 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
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
Senior QA Specialist(m/w/x)
Full-timeOn-siteSeniorVisp - CH12 Lonza AG
Senior QA Specialist, QA Project Management(m/w/x)
Full-timeOn-siteSeniorVisp - Lonza
Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)
Full-timeOn-siteSeniorVisp - Lonza
Senior QA Specialist, QA Operations(m/w/x)
Full-timeOn-siteSeniorVisp - Lonza
Senior QA Specialist, DPS (Drug Product Services)(m/w/x)
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