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 Responsibilities a: 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 Experience a: 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 Attributes a: Strong analytical, communication skills b: Leadership and problem solving Skills Educational Qualification BE Completed

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