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Serialization Manager / Serialization System Owner(m/w/x)
System ownership for serialization IT systems in GMP environment for rare disease therapies. Several years experience with serialization systems or packaging automation in GMP environment required. Bonus scheme, flexible hours, home office.
Anforderungen
- Bachelor’s degree in Natural Sciences, Business Administration, Information Technology, or comparable professional experience
- Several years of experience with serialization systems or secondary packaging automation in a GMP-regulated environment
- Strong knowledge of pharmaceutical serialization regulations
- Confident handling of complex IT systems and interfaces
- Structured, precise, and independent working style
- Strong analytical and problem-solving skills
- Ability to clearly communicate technical and regulatory topics to diverse stakeholders
- High level of reliability and resilience in a regulated environment
- Very good English skills; additional languages are an advantage
Aufgaben
- Act as System Owner for serialization IT systems
- Ensure compliant system operation in a GMP environment
- Manage SOPs and change control processes
- Conduct validation activities and periodic reviews
- Oversee user and access management
- Facilitate onboarding activities for new users
- Manage connectivity to regulatory hubs and authorities
- Coordinate serial number and master data exchange
- Administer products, SKUs, and product catalogs
- Support onboarding of new products and markets
- Implement system changes with stakeholders and vendors
- Assist with serialization-related projects and regulatory implementations
- Handle serialization alerts and support QA investigations
- Manage serialization-related fees and agreements
- Serve as the primary contact for serialization topics
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Lockere Unternehmenskultur
- Open corporate culture
Flexibles Arbeiten
- Flexible working hours
- Homeoffice
Boni & Prämien
- Bonus scheme
Mentoring & Coaching
- Structured onboarding
Weiterbildungsangebote
- Initial and continuing education
Gratis oder Vergünstigte Mahlzeiten
- Canteen
Parkplatz & Pendelvorteile
- Good transport connection
- Parking spot
Team Events & Ausflüge
- Employee events
Sonstige Zulagen
- Meal allowance
Gesundheits- & Fitnessangebote
- Company doctor
- Health measures
Mitarbeiterrabatte
- Employee discount
Firmenwagen
- Company car
Moderne Technikausstattung
- Employee mobile phone
- Laptop
Noch nicht perfekt?
- AOP HealthVollzeitmit HomeofficeBerufserfahrenWienab 45.080 / Jahr
- AOP Health
Application Owner – Veeva Platform(m/w/x)
Vollzeitmit HomeofficeSeniorWienab 45.080 / Jahr - AOP Health
Manager R&D Transformation, Adoption & Governance(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWienab 54.642 / Jahr - Brenntag Austria GmbH
Quality Assurance Manager Pharma & Food(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGuntramsdorfab 3.800 / Monat - Brenntag Austria GmbH
Fachexperte Pharma / GDP(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGuntramsdorfab 3.800 / Monat
Serialization Manager / Serialization System Owner(m/w/x)
System ownership for serialization IT systems in GMP environment for rare disease therapies. Several years experience with serialization systems or packaging automation in GMP environment required. Bonus scheme, flexible hours, home office.
Anforderungen
- Bachelor’s degree in Natural Sciences, Business Administration, Information Technology, or comparable professional experience
- Several years of experience with serialization systems or secondary packaging automation in a GMP-regulated environment
- Strong knowledge of pharmaceutical serialization regulations
- Confident handling of complex IT systems and interfaces
- Structured, precise, and independent working style
- Strong analytical and problem-solving skills
- Ability to clearly communicate technical and regulatory topics to diverse stakeholders
- High level of reliability and resilience in a regulated environment
- Very good English skills; additional languages are an advantage
Aufgaben
- Act as System Owner for serialization IT systems
- Ensure compliant system operation in a GMP environment
- Manage SOPs and change control processes
- Conduct validation activities and periodic reviews
- Oversee user and access management
- Facilitate onboarding activities for new users
- Manage connectivity to regulatory hubs and authorities
- Coordinate serial number and master data exchange
- Administer products, SKUs, and product catalogs
- Support onboarding of new products and markets
- Implement system changes with stakeholders and vendors
- Assist with serialization-related projects and regulatory implementations
- Handle serialization alerts and support QA investigations
- Manage serialization-related fees and agreements
- Serve as the primary contact for serialization topics
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Benefits
Lockere Unternehmenskultur
- Open corporate culture
Flexibles Arbeiten
- Flexible working hours
- Homeoffice
Boni & Prämien
- Bonus scheme
Mentoring & Coaching
- Structured onboarding
Weiterbildungsangebote
- Initial and continuing education
Gratis oder Vergünstigte Mahlzeiten
- Canteen
Parkplatz & Pendelvorteile
- Good transport connection
- Parking spot
Team Events & Ausflüge
- Employee events
Sonstige Zulagen
- Meal allowance
Gesundheits- & Fitnessangebote
- Company doctor
- Health measures
Mitarbeiterrabatte
- Employee discount
Firmenwagen
- Company car
Moderne Technikausstattung
- Employee mobile phone
- Laptop
Über das Unternehmen
AOP Health
Branche
Healthcare
Beschreibung
AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care.
Noch nicht perfekt?
- AOP Health
Application Owner (GxP / Validated Systems)(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWienab 45.080 / Jahr - AOP Health
Application Owner – Veeva Platform(m/w/x)
Vollzeitmit HomeofficeSeniorWienab 45.080 / Jahr - AOP Health
Manager R&D Transformation, Adoption & Governance(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWienab 54.642 / Jahr - Brenntag Austria GmbH
Quality Assurance Manager Pharma & Food(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGuntramsdorfab 3.800 / Monat - Brenntag Austria GmbH
Fachexperte Pharma / GDP(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenGuntramsdorfab 3.800 / Monat