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Senior QA Specialist, QA Project Management(m/w/x)
Managing GMP compliance for API production and contract manufacturing in life sciences. Batch release expertise and GMP experience in biopharma preferred. International project collaboration, cross-functional team advising.
Requirements
- University degree in Life Sciences (Microbiology, Biotechnology, Chemistry)
- First experience in GMP environment, preferably in biopharmaceutical industry
- Strong communication skills and experience working with stakeholders from different departments
- Experience with TrackWise, SAP, LIMS, and DMS
- Batch release expertise
- Fluency in English and German (written and verbal)
Tasks
- Ensure API production complies with Good Manufacturing Practice (GMP)
- Support contract manufacturing processes
- Advise development, production, and analytical teams on GMP aspects
- Check manufacturing documentation for conformity
- Process change controls
- Review and approve deviations and out-of-specification (OOS) results
- Act as the quality contact for clients
- Present during GMP audits
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- TrackWise
- SAP
- LIMS
- DMS
Benefits
Bonuses & Incentives
- Compensation programs that recognize high performance
Startup Environment
- Agile career and dynamic working culture
Purpose-Driven Work
- Inclusive and ethical workplace
Not a perfect match?
- LonzaFull-timeOn-siteSeniorVisp
- CH12 Lonza AG
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Senior QA Specialist, QA Project Management(m/w/x)
Managing GMP compliance for API production and contract manufacturing in life sciences. Batch release expertise and GMP experience in biopharma preferred. International project collaboration, cross-functional team advising.
Requirements
- University degree in Life Sciences (Microbiology, Biotechnology, Chemistry)
- First experience in GMP environment, preferably in biopharmaceutical industry
- Strong communication skills and experience working with stakeholders from different departments
- Experience with TrackWise, SAP, LIMS, and DMS
- Batch release expertise
- Fluency in English and German (written and verbal)
Tasks
- Ensure API production complies with Good Manufacturing Practice (GMP)
- Support contract manufacturing processes
- Advise development, production, and analytical teams on GMP aspects
- Check manufacturing documentation for conformity
- Process change controls
- Review and approve deviations and out-of-specification (OOS) results
- Act as the quality contact for clients
- Present during GMP audits
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- TrackWise
- SAP
- LIMS
- DMS
Benefits
Bonuses & Incentives
- Compensation programs that recognize high performance
Startup Environment
- Agile career and dynamic working culture
Purpose-Driven Work
- Inclusive and ethical workplace
About the Company
CH12 Lonza AG
Industry
Healthcare
Description
The company is a global leader in life sciences, dedicated to improving lives through innovative solutions.
Not a perfect match?
- Lonza
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