Computer System Validation

<p><p><b>Location : </b> Anywhere in INDIA / WFO.<br/><br/><b>Notice : </b> 30 days below.<br/><br/><b>Experience : </b> 7+ Years.<br/><br/><b>JD : </b><br/><br/><b>Primary Skills : </b> Computer System Validation.<br/><br/><b>Secondary Skills : </b> Validating RIMS, MES, SAP or Data Platform like Snowflake, ETL etc.</p><p><br/></p><p><b>Job Description : </b></p><p><br/></p><p>- Experience in Computer System Validation of Regulatory Information Management (RIM), Manufacturing, Data Analytics applications.</p><p><br/>- Must have experience in validating applications in RIM, Manufacturing or Data Platforms.<br/><br/>- Must have experience in Agile methodology and handled multiple releases in parallel.<br/><br/>- Extensive knowledge in CSV, CSV auditing, creation and revision of CSV documentation.<br/><br/>- 5+ years of experience in validating GxP application implementation, test script review, test execution review, test defect management.<br/><br/>- Has working experience in any one or two of the following domains Tool validation like ServiceNOW, Automation tools, JIRA.<br/><br/>- Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC.<br/><br/>- Application of FDA guidances and industry standards (i.e., GAMP) .<br/><br/>- Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams.<br/><br/>- Experience in drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report.<br/><br/>- Must be familiar with procedures, work instructions, forms and templates.<br/><br/>- Solid understanding of SDLC, Jira, QTest, automated test tools, code repository like bitbucket and change control/ management systems like ServiceNow.</p><br/></p> (ref:hirist.tech)