Roche
Healthcare
ITQualitySpecialistRDTDIAR&D
“IT Quality Specialist RDT DIA R&D at Roche. Skills: Computer System Validation (CSV), GxP, SDLC, Agile. Driving global validation efforts. providing expert guidance”
What You'll Achieve.
prevent, stop and cure diseases; ensure everyone has access to healthcare; power Roche through cutting-edge digital technologies; driving breakthroughs that truly matter for millions of patients
Industry & Context.
streamline resolution
What They're Looking For.
Must Have
six years of professional experience in CSV, supporting the lifecycle of COTS and custom software within regulated GxP environments, global regulations, FDA/EU GxP, 21 CFR Part 11, GAMP 5, Data Integrity, diverse testing methodologies, end-to-end SDLC, Agile frameworks, Scrum, SAFe, fluent English skills
Nice to Have
Product Development Processes specific to Medical Devices
What You'll Do.
Driving global validation efforts
providing expert guidance
authoring critical CSV documentation
Ensuring alignment with GxP
internal Roche standards
overseeing periodic system evaluations
Evaluating impact of changes
protect data integrity
supporting growth of scalable digital healthcare solutions
How You'll Work.
Team & Collaboration
Partnering with Business and Quality stakeholders; facilitate cross-functional collaboration; thriving within international, cross-functional project teams
Communication Scope
fluent English skills
Process & Methodology
global validation efforts
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