Computer System Specialist

Greetings from HCL Technologies!Hiring for "Computer system validation"Experience - 4 to 20 yearsLocation - Bangalore / Chennai / Hyderabad / Noida / PuneNotice Period -Immediate to 90 daysCTC- Open for discussionAbout the RoleExperience in Computer System Validation of Data platform applications like Data lake, Data Warehouse, Data Bricks etc. Must have experience in Agile methodology and handled multiple releases in parallel.ResponsibilitiesExtensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation.Experience with Data Platform applications project management, test script review, test execution review, test defect management.Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC.Application of FDA guidance’s and industry standards (i.e., GAMP).Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams.Experience in drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report.Must be familiar with procedures, work instructions, forms and templates.Solid understanding of SDLC, Jira, QTest, automated test tools, code repository like bitbucket and change control / management systems like ServiceNow.Required Skills1) Computer System Validation2) Test Case Review, Validation Plan, Validation Summary Report3) 21 CFR part 114) Validating SAP, ERP, LIMS, Data Platforms5) GAMP Guidelines, GxP Guidelines, Industry StandardsInterested candidates please drop mail to " "Regards,Kushma