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Job Role: Business Analyst In Bangalore
Experience:
Ø Min 5+ years of experience in working in a service level based preferably in the IT Quality domain
Ø Min 2+ years of practical GXP areas with exposure to regulatory affairs
Ø Min 4+ years in performing RCAs, CAPA and any other relevant IT services
Working Hours: General Shift.
Skills Required:
Pharma CSV, GAMP, IT Compliance, SDLC
Excellent oral and verbal Communication Skills
Additional Technical area to be Experienced for the current role:
Ø Excellence in CSV and compliance process understanding
Ø Able to take up IT quality coordinator roles at various stages of IT project
Ø Prepare Master Validation Plan/Report, Quality/Validation Plan/Report, IT Quality Risk Assessment and Qualification Protocol/Report.
Ø Functional and Technical Design Specifications below URS level, IQP/R, OQP/R, XQP/R, p-IQP/R, p-XQP/R
Role Description:
Ø Efficiently author/review yearly reports with respect to user setup and configuration management
Ø Efficiently author/review IT Periodic Evaluation reports
Ø Manage and Maintain periodic report tools
Ø Contribute towards achievement of project goals
Ø Demonstrate Pro-activeness and ownership
Ø Manage own time planning, multiple concurrent tasks, timely deliverables and be flexible
Ø Communicate and involve relevant stakeholders
Ø Enhancing good team spirit and high degree of knowledge sharing
Ø Deliver specific services that fulfil productivity/cost/quality/Timeliness KPI Criteria for stakeholders
Ø Develop plans, execute and deliver the services with acceptable service evaluations
Ø Ensure stakeholders evaluations are acted upon
Ø Ensure all service hours are logged accurately in CPT
Ø Read and understand all documentation related to IT shared services
Ø Keep all documentation on relevant services up to date
Ø To regularly communicate with management on the service status on improvement activities
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