Roles & Responsibilities:
- 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 Test automated test tools code repository like bitbucket and change control/ management systems like ServiceNow.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract