APQP Manager at Marmon/Keystone leading technical risk management and customer requirement execution across North America. Overseeing quality processes and leading a team of APQP Engineers.
About the role
- Quality Control Manager in pharmaceutical industry responsible for analysis and compliance to cGMP. Leading quality assurance in a collaborative environment at Roche sites in Kaiseraugst and Basel.
Responsibilities
- Prüfung von Analysen-Mäppchen auf Richtigkeit und Vollständigkeit gemäss cGMP-Richtlinien
- Bearbeitung von Deviations, CAPA und Changes
- Koordination gruppenübergreifender Freigabe- und Stabilitätsanalysen
- Erstellung und Aktualisierung von SOPs und GMP-Dokumenten
- Agieren als Produktverantwortliche/r / Single Point of Contact
- Mitarbeit in cross-funktionalen Projekten und Unterstützung bei Audits und Inspektionen
- Sicherstellung der Pharmakopöe-Konformität
Requirements
- abgeschlossene Ausbildung oder ein Studium (Chemie, Biologie, Pharmazie)
- mehrjährige Berufserfahrung im GMP-Umfeld, idealerweise im Quality-Bereich
- gewissenhaft, genau und routiniert
- Multitasking-Fähigkeiten
- fundierte EDV-Kenntnisse
- teamfähig und lösungsorientiert
- Verantwortungsbewusstsein für kontinuierliche Verbesserungsprozesse und Methoden (z.B. Lean Six Sigma)
- sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift
- hohe Kunden- und Dienstleistungsorientierung
Benefits
- Roche is an Equal Opportunity Employer
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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