Must Sharepoint Lists maintenance for project activities tracking Exp. Required Job Details Bilingual - Spanish and English required • 7-10 years' experience in Computer System Validation of SAAS systems, and Cloud systems • Must have experience in Agile methodology and handled multiple releases in parallel • 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