Overview
On Site
Full Time
Skills
SaaS
Cloud Computing
Agile
GAMP
Technical Drafting
Computerized System Validation
Regulatory Compliance
Reporting
Forms
Software Development Methodology
JIRA
Automated Testing
Bitbucket
Change Control
ServiceNow
Job Details
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 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, Quests, automated test tools, code repository like bitbucket and change control/ management systems like ServiceNow.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.