CSV (Computer System Validations)
Accenture
Chennai, Tamil Nadu
Job Description
About Accenture: Accenture Technology powers our clients’ businesses with innovative technologies—established and emerging—changing the way their people and customers experience work, life and entertainment. Join Accenture Technology and you’ll translate the operational needs of the world’s governments and leading businesses into the innovative technical solutions that will enable them to better serve their customers—your friends, family and neighbors.You’ll deliver everything from point solutions for a single business function to large, long-term outsourcing services, to complex systems integration installations spanning multiple businesses and functions. You’ll create custom-designed solutions or integrate our technology platforms with their operations.

Role :Application Designer
Role Description :Assist in defining requirements and designing applications to meet business process and application requirements.
Must Have Skills :CSV (Computer System Validations)
Good To Have Skills :No Technology Specialty

Job Requirements :
Key Responsibilities : a: Lead small teams and perform project validation activties 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

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 Methodology, Cloud-based environment, SAP, HP ALM, ServiceNow etc

Professional Attributes : a: Author and review key validation documents, write SOPs b: Train teams on client processes and controls c: Experience in supporting regulatory/ client audits, conducting internal audits d: Record and report compliance related measurement information for metrics reporting

Educational Qualification : a B E completed

Additional Information : a: Record and report compliance related measurement information for metrics reporting
Qualifications
15 years of full time education