Beschreibung

In this role, you will take charge of serialization systems, ensuring compliance and stability while coordinating with various stakeholders. Your day-to-day responsibilities will involve managing system operations, supporting product onboarding, and addressing regulatory requirements.

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

Benefits