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