09 Nov
|
Billennium
|
Manitoba
09 Nov
Billennium
Manitoba
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 workplace 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.
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📌 GMP Computer System Validation Analyst (Manitoba)
🏢 Billennium
📍 Manitoba