AOP Health
Application Owner – Veeva Platform(m/w/x)
Vollzeitmit HomeofficeSenior
Wien
ab 45.080 / Jahr
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AOAOP Health
Application Owner (GxP / Validated Systems)(m/w/x)
Wien
ab 45.080 / Jahr
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Managing full lifecycle of GxP-validated applications for rare disease therapies at a critical care provider. Several years of GxP IT application management experience and hands-on CSV expertise required. Vendor relationship management and incident coordination.
Anforderungen
- Degree in IT, Life Sciences, Engineering, or related field
- Several years of IT application management experience in GxP-regulated environment
- Hands-on CSV expertise
- Strong knowledge of EU GMP Annex 11, 21 CFR Part 11, GAMP 5
- Strong knowledge of risk-based validation and change control approaches
- Experience supporting audits and inspections
- Proven experience collaborating with external software vendors
- Advantageous: ISPE certification (CPGP) or GAMP 5 training
- Plus: ASQ certifications (CQA or CQE)
- Beneficial: ITIL Foundation certification
- Experience with ERP, QMS, LIMS, or document management systems in regulated environments
- Experience with 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
- Experience driving organizational change
- Familiarity with ITIL and service management principles
- Experience with Agile and/or DevOps methodologies
- Degree in IT, Life Sciences, Engineering, or related field
- Several years of IT application management experience in GxP-regulated environment
- Hands-on CSV expertise
- Strong knowledge of EU GMP Annex 11, 21 CFR Part 11, GAMP 5
- Strong knowledge of risk-based validation and change control approaches
- Experience supporting audits and inspections
- Proven experience collaborating with external software vendors
- Advantageous: ISPE certification (CPGP) or GAMP 5 training
- Plus: ASQ certifications (CQA or CQE)
- Beneficial: ITIL Foundation certification
- Experience with ERP, QMS, LIMS, or document management systems in regulated environments
- Experience with 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
- Experience driving organizational change
- Familiarity with ITIL and service management principles
- Experience with Agile and/or DevOps methodologies
Aufgaben
- Serve as the key interface between IT, QA, business stakeholders, and external vendors.
- Manage the full application lifecycle.
- Ensure reliable application performance and availability.
- Ensure compliant application upgrades and releases.
- Manage vendor relationships, SLAs, and support contracts.
- Coordinate incident, problem, and change management processes.
- Ensure validated systems remain compliant throughout their lifecycle.
- Oversee risk-based (GAMP 5) validation activities.
- Perform change impact assessments.
- Manage required validation documentation.
- Support audits and inspections.
- Conduct periodic system reviews.
- Ensure alignment with EU GMP Annex 11, 21 CFR Part 11, and ALCOA+ principles.
- Perform and document risk assessments.
- Ensure proper access management.
- Ensure segregation of duties.
- Maintain full traceability across requirements, testing, and validation documentation.
- Collaborate with QA on compliance expectations.
- Support continuous improvement of validation and governance processes.
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- CSV
- EU GMP Annex 11
- 21 CFR Part 11
- GAMP 5
- ITIL
- ERP
- QMS
- LIMS
- SaaS
- Cloud validation
Benefits
Lockere Unternehmenskultur
- Open corporate culture
- Collegial and committed team
Sinnstiftende Arbeit
- Opportunity to contribute ideas
- Independent work
Modernes Büro
- Modern working environment
Parkplatz & Pendelvorteile
- Good public transport connections
- Parking spot
Flexibles Arbeiten
- Flexible working hours
- Home office
Boni & Prämien
- Bonus
Team Events & Ausflüge
- Employee events
Mentoring & Coaching
- Structured onboarding
- Buddy system support
Moderne Technikausstattung
- Employee mobile phone
- Laptop
Weiterbildungsangebote
- Initial and continuing education
Gratis oder Vergünstigte Mahlzeiten
- Canteen
Sonstige Zulagen
- Meal allowance
Gesundheits- & Fitnessangebote
- Company doctor
- Health measures
Mitarbeiterrabatte
- Employee discount
Firmenwagen
- Company car
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AOP Health erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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Vollzeitmit HomeofficeBerufserfahrenWienab 54.642 / Jahr - Takeda Manufacturing Austria AG
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Vollzeitmit HomeofficeJuniorWienab 4.270,14 / Monat - MUELLBACHER Personalberatung
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AOAOP Health
Application Owner (GxP / Validated Systems)(m/w/x)
Wien
ab 45.080 / Jahr
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Managing full lifecycle of GxP-validated applications for rare disease therapies at a critical care provider. Several years of GxP IT application management experience and hands-on CSV expertise required. Vendor relationship management and incident coordination.
Anforderungen
- Degree in IT, Life Sciences, Engineering, or related field
- Several years of IT application management experience in GxP-regulated environment
- Hands-on CSV expertise
- Strong knowledge of EU GMP Annex 11, 21 CFR Part 11, GAMP 5
- Strong knowledge of risk-based validation and change control approaches
- Experience supporting audits and inspections
- Proven experience collaborating with external software vendors
- Advantageous: ISPE certification (CPGP) or GAMP 5 training
- Plus: ASQ certifications (CQA or CQE)
- Beneficial: ITIL Foundation certification
- Experience with ERP, QMS, LIMS, or document management systems in regulated environments
- Experience with 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
- Experience driving organizational change
- Familiarity with ITIL and service management principles
- Experience with Agile and/or DevOps methodologies
- Degree in IT, Life Sciences, Engineering, or related field
- Several years of IT application management experience in GxP-regulated environment
- Hands-on CSV expertise
- Strong knowledge of EU GMP Annex 11, 21 CFR Part 11, GAMP 5
- Strong knowledge of risk-based validation and change control approaches
- Experience supporting audits and inspections
- Proven experience collaborating with external software vendors
- Advantageous: ISPE certification (CPGP) or GAMP 5 training
- Plus: ASQ certifications (CQA or CQE)
- Beneficial: ITIL Foundation certification
- Experience with ERP, QMS, LIMS, or document management systems in regulated environments
- Experience with 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
- Experience driving organizational change
- Familiarity with ITIL and service management principles
- Experience with Agile and/or DevOps methodologies
Aufgaben
- Serve as the key interface between IT, QA, business stakeholders, and external vendors.
- Manage the full application lifecycle.
- Ensure reliable application performance and availability.
- Ensure compliant application upgrades and releases.
- Manage vendor relationships, SLAs, and support contracts.
- Coordinate incident, problem, and change management processes.
- Ensure validated systems remain compliant throughout their lifecycle.
- Oversee risk-based (GAMP 5) validation activities.
- Perform change impact assessments.
- Manage required validation documentation.
- Support audits and inspections.
- Conduct periodic system reviews.
- Ensure alignment with EU GMP Annex 11, 21 CFR Part 11, and ALCOA+ principles.
- Perform and document risk assessments.
- Ensure proper access management.
- Ensure segregation of duties.
- Maintain full traceability across requirements, testing, and validation documentation.
- Collaborate with QA on compliance expectations.
- Support continuous improvement of validation and governance processes.
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- CSV
- EU GMP Annex 11
- 21 CFR Part 11
- GAMP 5
- ITIL
- ERP
- QMS
- LIMS
- SaaS
- Cloud validation
Benefits
Lockere Unternehmenskultur
- Open corporate culture
- Collegial and committed team
Sinnstiftende Arbeit
- Opportunity to contribute ideas
- Independent work
Modernes Büro
- Modern working environment
Parkplatz & Pendelvorteile
- Good public transport connections
- Parking spot
Flexibles Arbeiten
- Flexible working hours
- Home office
Boni & Prämien
- Bonus
Team Events & Ausflüge
- Employee events
Mentoring & Coaching
- Structured onboarding
- Buddy system support
Moderne Technikausstattung
- Employee mobile phone
- Laptop
Weiterbildungsangebote
- Initial and continuing education
Gratis oder Vergünstigte Mahlzeiten
- Canteen
Sonstige Zulagen
- Meal allowance
Gesundheits- & Fitnessangebote
- Company doctor
- Health measures
Mitarbeiterrabatte
- Employee discount
Firmenwagen
- Company car
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens AOP Health erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
AOP Health
Branche
Pharmaceuticals
Beschreibung
AOP Health is the European pioneer for integrated therapies for rare diseases and in critical care.
Noch nicht perfekt?
- AOP Health
Application Owner – Veeva Platform(m/w/x)
Vollzeitmit HomeofficeSeniorWienab 45.080 / Jahr - AOP Health
Serialization Manager / Serialization System Owner(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWienab 54.642 / Jahr - AOP Health
Manager R&D Transformation, Adoption & Governance(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWienab 54.642 / Jahr - Takeda Manufacturing Austria AG
Validation Specialist BioLife Laboratory Information Management System(m/w/x)
Vollzeitmit HomeofficeJuniorWienab 4.270,14 / Monat - MUELLBACHER Personalberatung
IT Applikationsbetreuer:in Laborinformationssysteme (LIS)(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWienab 3.800 / Monat