Job Description

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Summary of Work
1 Support Computer Systems Validation activities across IT for hosted SAAS and on premise applications ie Application Management RD SGA Infrastructure Service Desk Security and IT Lab Systems
Author the validation deliverables Validation Plan OQ PQ Test Scripts RTM Summary Reports Risk Assessments and Data Integrity forms
Provide IT Quality support and guidance for GxP and Non GxP systems implementation and maintenance for systems
Administrator and support IT Change Controls to ensure adequate documentation segregation of duty adherence to SOP GAMP5 and DI guidance and industry best practices
Work close with Project Managers and IT systems owner lead to plan evaluate and analysis validation testing scope timeline and effort
2 Support Technical writing SOPs Forms Policies etc and Training management
Update and review technical documents and procedures to ensure it aligns with current process
Ensure appropriate and adequate training curriculum is assigned to IT team members
Scope
1 Creating the validation deliverables Risk Assessment Data Integrity Validation Plan URS CSD OQ PQ RTM Summary Report Test problem reports memos to cover the deviations by following defined SDLC process
2 Quality and Compliance support to GxP and NonGxP applications
3 Work with CR owner to review the final deliverables and arrangements before closing of the CR
4 Technical documentation writing
5 Tracking of the change requests and status of the change requests
6 Create review and approvals of weekly monthly and quarterly reports like Weekly Terminations Security Review Report Object Migration report Quarterly access Reviews
7 Support IT system compliance related issues and leading the efforts related to compliance
8 As needed work with QA team to determine the deliverables required for an IT CR case by case basis
At least 3 Mandatory Skills required
Computer System Validation CSV
Quality Assurance QA
SoX compliance
Skills:
Mandatory Skills : Regulatory & Compliance - Computer system validation,Regulatory & Compliance - Process Quality Assurance
About Company:
LTIMindtree is a global technology consulting and digital solutions company that enables enterprises across industries to reimagine business models, accelerate innovation, and maximize growth by harnessing digital technologies. As a digital transformation partner to more than 700 clients, LTIMindtree brings extensive domain and technology expertise to help drive superior competitive differentiation, customer experiences, and business outcomes in a converging world. Powered by 86,000+ talented and entrepreneurial professionals across more than 40 countries, LTIMindtree -- a Larsen & Toubro Group company -- solves the most complex business challenges and delivers transformation at scale. For more information, please visit https://www.ltimindtree.com/.