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Senior Associate Serialization

AOP Orphan Pharmaceuticals GmbH -
Wien, W

Jetzt bewerben

Details zur Stelle

Vollzeit

Vollständige Stellenbeschreibung

Full-time

Vienna

We are looking for a Senior Associate Serialization who ensures the compliant and efficient execution of serialization processes in accordance with EU FMD, DSCSA, and other applicable regulatory requirements.

What Your Day To Day Will Look Like

Execute and monitor serialization processes in compliance with EU FMD, DSCSA, and country-specific regulations
Act as a user for serialization IT systems (e.g., Avarto, Tracekey, Melior, LSPedia), ensuring secure, stable, and compliant system functionality
Support managing and monitoring of master data (GTIN/GS1), product catalogs (e.g., BrandSync), and system configurations for new products and markets
Coordinate serial number uploads and data exchange with regional hubs (e.g., EU Hub), authorities, CMOs, and wholesalers
Support and partially coordinate onboarding of new products, CMOs, and regions (system configuration, testing, aggregation, documentation)
Contribute to change control processes, periodic reviews, and validation activities in collaboration with QA and IT
Support serialization alert investigations and prepare incident documentation
Identify process or system improvement opportunities and propose optimization measures

Your Qualifications And Experience

Degree in Business Administration, Information Technology, Supply Chain Management, Life Sciences, or comparable qualification
Experience with serialization systems or complex database systems prefered
Basic understanding of pharmaceutical serialization regulations (EU FMD, DSCSA) prefered
Good knowledge of GxP requirements and validation principles
Analytical mindset and strong data accuracy
Structured, independent, and solution-oriented working style
Strong communication skills and ability to work cross-functionally
Fluent in English (German advantageous)

Our offer

An open corporate culture with the opportunity to contribute your own ideas
Working independently in a collegial and committed team
Modern working environment with good public transport connections (U4 - Heiligenstadt)
Flexible working hours (flexitime/time-out days), bonus scheme, additional benefits and employee events
Structured onboarding and support through a buddy system
Due to legal requirements, we are obliged to disclose the collective agreement minimum salary, which is EUR 45.080,- gross per year, based on full-time employment. However, our actual remuneration packages are market-oriented and aligned with your qualifications and professional experience.

If you would like to work as a team player in an international environment and can identify with our values "Agile, Ambitious, Aligned, Accountable and Appreciative", then: Take this CHANCE and

APPLY NOW

Please submit your application exclusively via the application link.

Introduction

Main Benefits

Bonus

Homeoffice

Employee mobile phone

Flexible working hours

Laptop

Initial and continuing education

Canteen

Good transport connection

Employee events

Meal allowance

Company doctor

Parking spot

Healthmeasures

Employee discount

Your Contact

Kenny Trappl

Talent Acquisition Manager

Jetzt bewerben

Erweiterte Suche

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