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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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- TrackWise
- SAP
- LIMS
- DMS
Benefits
Boni & Prämien
- Compensation programs that recognize high performance
Startup-Atmosphäre
- Agile career and dynamic working culture
Sinnstiftende Arbeit
- Inclusive and ethical workplace
Noch nicht perfekt?
- LonzaVollzeitnur vor OrtSeniorVisp
- 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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- TrackWise
- SAP
- LIMS
- DMS
Benefits
Boni & Prämien
- Compensation programs that recognize high performance
Startup-Atmosphäre
- Agile career and dynamic working culture
Sinnstiftende Arbeit
- Inclusive and ethical workplace
Über das Unternehmen
CH12 Lonza AG
Branche
Healthcare
Beschreibung
The company is a global leader in life sciences, dedicated to improving lives through innovative solutions.
Noch nicht perfekt?
- Lonza
Senior QA Specialist/QA Project Manager(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
Senior QA Specialist(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior QA Specialist, QA Operations(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior QA Specialist, DPS (Drug Product Services)(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)
Vollzeitnur vor OrtSeniorVisp