business analyst in serialization and traceability
ориентир по рынку
вакансия
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243 654 ₽
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О рекламодателе
ОБЩЕСТВО С ОГРАНИЧЕННОЙ ОТВЕТСТВЕННОСТЬЮ "ЦЕНТР НАЦИОНАЛЬНЫХ ИНТЕЛЛЕКТУАЛЬНЫХ СИСТЕМ" ИНН: 9704271170
описание
Galderma develops products in Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. It aims to become the leading dermatology company in the world.
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
Private healthcare and life insurance
Pension plan
Health and wellbeing benefits, including access to fitness support