CSV (Computer System Validations) Application Designer

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• Project Role :Application Designer
• Project Role Description :Assist in defining requirements and designing applications to meet business process and application requirements.
• Management Level :8
• Work Experience :8-10 years
• Work location :Bengaluru
• Must Have Skills :CSV (Computer System Validations)
• Good To Have Skills :Life Sciences
• Job Requirements :
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  • 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: Knowledge of 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 of full time education