CSV Engineer
CSV Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
- 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 Service NOW 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 Quests automated test tools code repository like bitbucket and change control/ management systems like ServiceNow.
Employment Type
Full Time
