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Senior QA Specialist/QA Project Manager(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- TrackWise
- LIMS
- DMS
- SAP
Benefits
Boni & Prämien
- Performance-based compensation programs
Karriere- und Weiterentwicklung
- Agile career
Lockere Unternehmenskultur
- Dynamic working culture
Sinnstiftende Arbeit
- Inclusive and ethical workplace
Noch nicht perfekt?
- CH12 Lonza AGVollzeitnur vor OrtSeniorVisp
- CH12 Lonza AG
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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
Senior QA Specialist/QA Project Manager(m/w/x)
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- TrackWise
- LIMS
- DMS
- SAP
Benefits
Boni & Prämien
- Performance-based compensation programs
Karriere- und Weiterentwicklung
- Agile career
Lockere Unternehmenskultur
- Dynamic working culture
Sinnstiftende Arbeit
- Inclusive and ethical workplace
Über das Unternehmen
Lonza
Branche
Pharmaceuticals
Beschreibung
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
Noch nicht perfekt?
- CH12 Lonza AG
Senior QA Specialist(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
Senior QA Specialist, QA Project Management(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(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