Accenture | Let there be change
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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 :
- 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
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