Computer System Validation

22 hours ago

Bengaluru, Karnataka, India Prophecy Technologies Full time ₹ 15,00,000 - ₹ 25,00,000 per year

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.

  • 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 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

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