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Head of QA Support (Shop Floor and Batch Record Review)(m/w/x)
Oversight of QA Documentation and Shop Floor teams, reviewing Aseptic Processing Simulations for Drug Product manufacturing at a global biopharmaceutical manufacturer. Extensive Drug Product QA and people leadership experience essential. Leading QA teams across multiple global manufacturing sites.
Anforderungen
- University degree in Chemistry, Biology, Biotechnology, or related field
- Experience in people leadership and strategic roles
- Valuable experience in QA department specifically Drug Product
- Fluent English language skills
- Advantageous German language skills
Aufgaben
- Oversee the QA Documentation and Shop Floor teams
- Implement and execute the QA Oversight program
- Monitor routine manufacturing and testing activities
- Review and approve Aseptic Processing Simulations
- Develop APS strategies, annual plans, and protocols
- Perform batch record reviews for paper and MES
- Represent QA during MES implementation projects
- Manage the archiving of paper and digital documents
- Lead Deviation Review Board meetings
- Provide GXP-related training to operations personnel
- Author and approve GMP-relevant documents and SOPs
- Support continuous improvement of the Quality Management System
- Prepare batch release documentation for the responsible person
- Coordinate with customers regarding QA operations topics
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Benefits
Boni & Prämien
- Performance-based compensation programs
Mitarbeiterrabatte
- Lifestyle benefits
- Leisure benefits
Familienfreundlichkeit
- Family benefits
Karriere- und Weiterentwicklung
- Agile career
Lockere Unternehmenskultur
- Dynamic work culture
Sinnstiftende Arbeit
- Inclusive and ethical workplace
Noch nicht perfekt?
- LonzaVollzeitnur vor OrtSeniorVisp
- Lonza
Head of QA Mammalian(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
QA Specialist, Batch Record Review(m/w/x)
Vollzeitnur vor OrtJuniorVisp - ten23 health
Head of Quality & GMP Operations(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
QA Automation Specialist - Batch Record Review(m/w/x)
Vollzeitnur vor OrtKeine AngabeVisp
Head of QA Support (Shop Floor and Batch Record Review)(m/w/x)
Oversight of QA Documentation and Shop Floor teams, reviewing Aseptic Processing Simulations for Drug Product manufacturing at a global biopharmaceutical manufacturer. Extensive Drug Product QA and people leadership experience essential. Leading QA teams across multiple global manufacturing sites.
Anforderungen
- University degree in Chemistry, Biology, Biotechnology, or related field
- Experience in people leadership and strategic roles
- Valuable experience in QA department specifically Drug Product
- Fluent English language skills
- Advantageous German language skills
Aufgaben
- Oversee the QA Documentation and Shop Floor teams
- Implement and execute the QA Oversight program
- Monitor routine manufacturing and testing activities
- Review and approve Aseptic Processing Simulations
- Develop APS strategies, annual plans, and protocols
- Perform batch record reviews for paper and MES
- Represent QA during MES implementation projects
- Manage the archiving of paper and digital documents
- Lead Deviation Review Board meetings
- Provide GXP-related training to operations personnel
- Author and approve GMP-relevant documents and SOPs
- Support continuous improvement of the Quality Management System
- Prepare batch release documentation for the responsible person
- Coordinate with customers regarding QA operations topics
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Benefits
Boni & Prämien
- Performance-based compensation programs
Mitarbeiterrabatte
- Lifestyle benefits
- Leisure benefits
Familienfreundlichkeit
- Family benefits
Karriere- und Weiterentwicklung
- Agile career
Lockere Unternehmenskultur
- Dynamic work 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?
- Lonza
Senior QA Specialist, DPS (Drug Product Services)(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
Head of QA Mammalian(m/w/x)
Vollzeitnur vor OrtSeniorVisp - Lonza
QA Specialist, Batch Record Review(m/w/x)
Vollzeitnur vor OrtJuniorVisp - ten23 health
Head of Quality & GMP Operations(m/w/x)
Vollzeitnur vor OrtSeniorVisp - CH12 Lonza AG
QA Automation Specialist - Batch Record Review(m/w/x)
Vollzeitnur vor OrtKeine AngabeVisp