Computer System Validation

1 week ago


Bengaluru, India Prophecy Technologies Full time

Location : Anywhere in INDIA / WFO.Notice : 30 days below.Experience : 7+ Years.JD : Primary Skills : Computer System Validation.Secondary Skills : Validating RIMS, MES, SAP or Data Platform like Snowflake, ETL etc.Job Description : - Experience in Computer System Validation of Regulatory Information Management (RIM), Manufacturing, Data Analytics applications.- Must have experience in validating applications in RIM, Manufacturing or Data Platforms.- Must have experience in Agile methodology and handled multiple releases in parallel.- Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation.- 5+ years of experience in validating GxP application implementation, test script review, test execution review, test defect management.- Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA.- 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 guidances 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. (ref:hirist.tech)



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