CSV (Computer System Validations) Application Designer

About Accenture: Accenture is a leading global professional services company, providing a broad range of services in strategy and consulting, interactive, technology and operations, with digital capabilities across all of these services. We combine unmatched experience and specialized capabilities across more than 40 industries — powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. With 514,000 people serving clients in more than 120 countries, Accenture brings continuous innovation to help clients improve their performance and create lasting value across their enterprises. Visit us at www.accenture.com

• 
  
• Project Role :Application Designer
• Project Role Description : Assist in defining requirements and designing applications to meet business process and application requirements.
• Management Level :7
• Work Experience :12-15 years
• Work location :Bengaluru
• Must Have Skills : CSV (Computer System Validations)
• Good To Have Skills : Life Sciences
• Job Requirements :
  • 
    
  • Key Responsibilities : a: Lead a team and drive overall project validation activities b: Represent the compliance / validation team in internal and client meetings and report metrics to management c: Collaborate with and coach all teams to ensure client processes and validation goals are understood and followed/met d: Ability to develop and maintain an effective relationship with client and other stake holders e: Experience in facing regulatory/ client audits, conducting internal audits
    
  • 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: Methods, Technologies and Tools such as Agile, Cloud-based environment, SAP, HP ALM, ServiceNow etc e: Ability to make decisions independently and to resolve issues appropriately to achieve a desired result or impact
    
  • Professional Attributes: a: Strong analytical, communication skills b: Leadership and problem solving Skills
    
  • Educational Qualification: BE Completed

15 years of full time education