28 сен

qa engineer (manual) for GxP systems

ориентир по рынку
вакансия зп не указана
в среднем 292 800 ₽
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описание

Galderma is a dermatology company with a science-based portfolio of brands and services spanning Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. It operates in approximately 90 countries.

задачи

  • Define and manage end-to-end validation strategies and plans
  • Prepare and maintain validation documentation, including risk assessments, validation plans, functional and technical specifications, test protocols, test execution reports, and final validation reports
  • Coordinate and participate in test execution and review
  • Manage deviations, non-conformities, and follow-up actions
  • Ensure systems remain in a validated state following changes and updates
  • Collaborate with IT Compliance, Quality, business teams, and technical colleagues
  • Support functional test scenarios and ensure appropriate test data is available
  • Provide validation expertise throughout implementation and operational activities

требования

  • Strong expertise in GxP and Computerized System Validation
  • Hands-on experience preparing and managing validation documentation
  • Experience managing the full validation lifecycle for computerized systems
  • Strong understanding of testing, risk assessments, deviations, and validation controls
  • Experience in pharmaceutical, life sciences, or another highly regulated environment
  • Strong attention to detail and a structured approach to documentation
  • Ability to manage validation activities independently from start to finish
  • Strong communication and collaboration skills across technical and business teams
  • Будет плюсом: experience with serialization or traceability systems

условия

  • Competitive reward package
  • Private healthcare and life insurance
  • Pension plan
  • Health and wellbeing benefits, including access to fitness support
  • Annual leave and additional employee benefits
  • Learning and development opportunities
  • International, collaborative environment with ownership and impact
  • 4 Days onsite from 2027

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