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.