Computer System Validation

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)