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AOAOP Health

Application Owner (GxP / Validated Systems)(m/w/x)

Wien
from 45,080 / year
Full-timeWith Home OfficeExperienced
Apply now

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.

Requirements

  • 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

Tasks

  • 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.

Work Experience

  • approx. 1 - 4 years

Education

  • Bachelor's degree

Languages

  • English – Business Fluent

Tools & Technologies

  • CSV
  • EU GMP Annex 11
  • 21 CFR Part 11
  • GAMP 5
  • ITIL
  • ERP
  • QMS
  • LIMS
  • SaaS
  • Cloud validation

Benefits

Informal Culture

  • Open corporate culture
  • Collegial and committed team

Purpose-Driven Work

  • Opportunity to contribute ideas
  • Independent work

Modern Office

  • Modern working environment

Parking & Commuter Benefits

  • Good public transport connections
  • Parking spot

Flexible Working

  • Flexible working hours
  • Home office

Bonuses & Incentives

  • Bonus

Team Events

  • Employee events

Mentorship & Coaching

  • Structured onboarding
  • Buddy system support

Modern Equipment

  • Employee mobile phone
  • Laptop

Learning & Development

  • Initial and continuing education

Free or Subsidized Food

  • Canteen

Additional Allowances

  • Meal allowance

Healthcare & Fitness

  • Company doctor
  • Health measures

Corporate Discounts

  • Employee discount

Company Vehicle

  • Company car
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of AOP Health and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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