Computer System Validation
1 week ago
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.
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.
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