Possible locations
  • Bialystok
  • Bydgoszcz
  • Czestochowa
  • Gdansk
  • Gliwice
  • Katowice
  • Kielce
  • Cracow
  • Lublin
  • Lodz
  • Pila
  • Poznan
  • Rzeszow
  • Szczecin
  • Torun
  • Warsaw
  • Wroclaw
  • Remote work

Join our team working on a project for one of the largest pharmaceutical companies in the world and have an impact on the lives and health of more than 15 million patients! If you are interested in working with top-class scientists from Silicon Valley/Western Europe, and helping them to fight cancer and other difficult diseases by accelerating IT potential do not hesitate to apply!

Your main tasks as validator will include maintaining the quality of computerized systems regulated by pharmaceutical law throughout the software lifecycle as well as being Software Quality Assurance Coordinator for validated safety critical computerized systems.

Your role

  • Determine validation approach, identify deliverables needed or impacted by a project/enhancement or change for GXP computerized systems
  • Responsible for the review of software documentation according to CSV corporate SOPs, and regulatory guidance
  • Provide estimates and forecast validation activities for a project
  • Author validation plans/reports, review test plans/reports (and other deliverables) to assess and notify that system is ready to go life
  • Determine testing strategy, requirements, and acceptance criteria
  • Liaison with business quality/informatics quality to ensure compliance with corporate quality policies and standards
  • Coordinate and advise on all validation activities on a global level/organizational level for system/project

Your skills
  • 3+ years of experience in IT & Software Validation (CSV, GAMP), preferably in a pharma environment
  • Experience in authoring validation plans, reports, and deliverable registries
  • Experience in authoring or reviewing validation related deliverables, records, and other evidence
  • Experience in software development lifecycle processes (SDLC), models, and standards in the pharmaceutical industry (or other regulated)
  • Experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11

Job no. 220524-1TSYX

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