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 : NA
Minimum 5 year(s) of experience is required
Educational Qualification : BE

Key Responsibilities a: Authoring and peer review of key validation documents as per Good Documentation Practices b: Perform and support compliance / validation activities c: Collaborate with and coach all teams to ensure client processes and validation goals are understood and followed/met Technical Experience a: Knowledge of Pharma Regulatory Compliance and CSV b: Knowledge of GxP environment with experience in validation life cycle and V-Model c: Good understanding of Good Documentation Practices d: GAMP5 Guidelines FDA Guidelines e: Validation life cycle of regulated projects Professional Attributes a Strong analytical, communication skills b Problem solving Skills Educational Qualification BE Completed Additional Information CSV, Validation, 21 CFR Part 11 and computerized system validation

BE

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