Project Role : Application Designer
Project Role Description : Assist in defining requirements and designing applications to meet business process and application requirements.
Must have skills : Computer System Validation (CSV)
Good to have skills : NA
Minimum 5 year(s) of experience is required
Educational Qualification : 15 years full time education

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

15 years full time education

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