GMP compliance and validation documentation anchor this Validation Analyst position at Roche. Support digital solutions through structured planning, testing, and qualification activities.
This role supports validation activities in a regulated life sciences setting at the intersection of technology, quality, and business processes. You will ensure solutions meet applicable compliance requirements while documenting plans, protocols, reports, and change controls. Collaboration with QA SMEs and cross-functional teams is central to testing and qualification.
Key Responsibilities:
- Ensure digital solutions align with GMP and data integrity guidelines
- Prepare validation plans, protocols, reports, and change controls
- Collaborate with QA SMEs on testing and qualification
- Execute test cases and analyze documented results
- Drive improvements in validation processes, tools, and methodologies
Requirements:
- Demonstrate knowledge of current GxP requirements
- Write validation documentation meeting established standards
- Validate statistical and data-driven models
- Understand Release Management processes and controls
- Know business or end-user applications and lifecycle models
Use GMP validation, data integrity, documentation, and qualification expertise to support compliant digital solutions at Roche.