qa engineer (manual) for GxP systems

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