Business Analyst

Project Role :Business Analyst


Project Role Description :Analyze an organization and design its processes and systems, assessing the business model and its integration with technology. Assess current state, identify customer requirements, and define the future state and/or business solution. Research, gather and synthesize information.
Must have skills :Computer System Validation (CSV)

Good to have skills :Test Data Management Implementation, AAAP (Accenture Advanced Analytics Platform)
Minimum 5 year(s) of experience is required

Educational Qualification :be

Key Responsibilitiesa:Lead small teams and perform project validation activities b:Represent the compliance / validation team in internal meetings and gather data for metrics to report to management c:Collaborate with and coach all teams to ensure client processes and validation goals are understood and followed/met d:FDA and other regulatory guidelines
Technical Experiencea:Knowledge of Pharma Regulatory Compliance and CSV b:Knowledge of End-to-End CSV in GxP environment with deep experience in validation life cycle and V-Model c:Good understanding of Pharma Regulatory requirements including CFR Part 11 and GAMP5 guidelines d:Experience in V-Model and Validation life cycle of regulated projects e:GxP Awareness including Good Documentation Practices f:Experience in supporting external audits
Professional Attributesa:Strong analytical, communication skills b:Leadership and problem solving Skills
Educational QualificationBE Completed

Qualification

be