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
a Author the validation deliverables Validation Plan OQ PQ Test Scripts RTM Summary Reports Risk Assessments and Data Integrity forms
b Provide IT Quality support and guidance for GxP and NonGxP systems implementation and maintenance for systems
c Administrator and support IT Change Controls to ensure adequate documentation segregation of duty adherence to SOP GAMP5 and DI guidance and industry best practices
d Work close with Project Managers and IT systems ownerlead to plan evaluate and analysis validationtesting scope timeline and effort
2 Support Technical writing SOPs Forms Policies etc and Training management
a Update and review technical documents and procedures to ensure it aligns with current process
b Ensure appropriate and adequate training curriculum is assigned to IT team members
Scope
1 Creating the validation deliverablesRisk 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
Skills
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/.