Application Owner (GxP / Validated Systems)

AOP Orphan Pharmaceuticals GmbH -
Wien, W

Jetzt bewerben

Details zur Stelle

Vollzeit

Vollständige Stellenbeschreibung

Full-time

Vienna

We are looking for an Application Owner with hands-on Computer System Validation (CSV) experience in a GxP-regulated environment to ensure compliant operation and lifecycle management of validated systems. You will serve as the key interface between IT, Quality Assurance, business stakeholders, and external vendors to ensure stable, secure, and inspection-ready systems.

What Your Day To Day Will Look Like

Own the full application lifecycle, ensuring reliable performance, availability, and compliant upgrades/releases.
Manage vendor relationships, SLAs, and support contracts.
Coordinate incident, problem, and change management processes.
Ensure validated systems remain compliant throughout their lifecycle, overseeing risk‑based (GAMP 5) validation activities, change impact assessments, and required documentation.
Support audits and inspections, conduct periodic system reviews, and ensure alignment with EU GMP Annex 11, 21 CFR Part 11, and ALCOA+ data integrity principles.
Perform and document risk assessments, ensure proper access management and segregation of duties, and maintain full traceability across requirements, testing, and validation documentation.
Collaborate closely with QA on compliance expectations and support continuous improvement of validation and governance processes.

Your Qualifications And Experience

Degree in IT, Life Sciences, Engineering, or a related field, plus several years of IT application management experience in a
GxP‑regulated environment with hands‑on CSV expertise.
Strong knowledge of EU GMP Annex 11, 21 CFR Part 11, GAMP 5, and risk‑based validation and change control approaches; experience supporting audits and inspections.
Proven experience collaborating with external software vendors.
ISPE certification (e.g., CPGP) or GAMP 5 training is an advantage
ASQ certifications such as CQA or CQE are a plus
ITIL Foundation certification beneficial
Experience with ERP, QMS, LIMS, or document management systems in regulated environments, including SaaS/cloud validation
Background in pharmaceutical, biotech, or medical device industries
Strong understanding of data integrity and security principles
Experience working in complex, fast‑paced environments and driving organizational change
Familiarity with ITIL and service management principles
Experience with Agile and/or DevOps methodologies

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

What Your Day To Day Will Look Like

Your Qualifications And Experience

Our offer

Introduction

Main Benefits

Your Contact

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