Lonza
Senior QA Expert, Manufacturing (m/w/x)
Vollzeitmit HomeofficeSenior
Stein (AR)
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Leading sterility assurance strategy and contamination control for aseptic processing at a global pharmaceutical manufacturer. Expertise in EU GMP Annex 1 and hands-on implementation required. Relocation assistance and agile career path.
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Anforderungen
- Expertise in sterility assurance and EU GMP Annex 1
- Hands-on experience implementing Annex 1 requirements
- Strong knowledge of Contamination Control Strategy (CCS)
- Ability to develop, challenge, and improve contamination control programs
- Extensive experience in aseptic processing
- Experience with media fills (APS)
- Experience with contamination risk management
- Experience with sterile manufacturing operations
- Proactive and solution-oriented mindset
- Passion for identifying root causes
- Partnering closely with production teams
- Implementing sustainable corrective actions
- Excellent communication and influencing skills
- Fluency in English
- Confidence to represent organization during audits
- German language skills (advantageous)
- Audit experience (advantageous)
Aufgaben
- Lead site sterility assurance strategy and ensure regulatory compliance
- Drive and enhance contamination control strategy
- Provide expert oversight of contamination control activities
- Provide expert oversight of environmental monitoring
- Provide expert oversight of cleaning and disinfection
- Provide expert oversight of aseptic manufacturing activities
- Act as sterility assurance subject matter expert
- Support facility design and qualification
- Support validation activities
- Support technology transfers
- Support new product introductions
- Support implementation of innovative technologies
- Champion a culture of quality and continuous improvement
- Lead risk assessments
- Lead trend analysis
- Lead training programs
- Lead initiatives to strengthen sterility assurance performance
- Represent Quality Assurance during inspections and audits
- Represent Quality Assurance during regulatory interactions
- Ensure inspection readiness
- Foster cross-functional collaboration
- Shape the future sterility assurance framework
Berufserfahrung
ca. 4 - 6 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – fließend
Deutsch – Grundkenntnisse
Benefits
Sonstige Vorteile
- Relocation assistance
Karriere- und Weiterentwicklung
- Agile career
Lockere Unternehmenskultur
- Dynamic work culture
Sinnstiftende Arbeit
- Inclusive and ethical workplace
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Lonza erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei LonzaÜber das Unternehmen
LO
PharmaceuticalsStein (AR)
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
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