Skills

I have worked on a variety of   Computerized System Validation (CSV) projects of which I have gained expertise in the Agile Methodology, SDLC validation deliverables and the key regulations driving CSV. I worked for two of the world’s largest pharma companies and have experience in devising end-to-end CSV strategies and preparing validation documents such as compliance analysis, validation plan, risk assessment, user requirement specifications, test cases, test protocol, IQ, OQ, PQ, test reports,  trace matrix, validation reports, change orders, SOPs.  

Refrences

As a risk analyst I helped one of the world's largest life sciences company in analyzing and driving the IT compliance process from a regulatory and compliance standpoint.

Time and Spatial Flexiblity

Open for travel and relocation

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