Overview
On Site
Full Time
Skills
Computerized System Validation
Quality Management
Business Analysis
GxP
ServiceNow
GAMP
Business Requirements Gathering
User Stories
Design Documentation
Risk Assessment
Test Plans
Communication
Software Development Methodology
Project Management
JIRA
Management
Job Details
Role & Responsibilities:
- 3-7 years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area.
- 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.
- pplication of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21CFRpat11 and Risk Based Approach with the ability to guide the project teams.
- Expertise in documenting / guiding various SDLR Deliverables including Requirements Specification/ User Stories, Criticality Assessment, Test Plan, Design Documentation, Validation Plan, Risk Assessment, Validation Strategy / Test Planning, Validation / Test Summary, Requirement Trace Matrix.
- Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner.
- bility to work with project team to facilitate interaction between Project team and Business Stake holders.
- bility to manage and provide guidance / train the team on Policies, end to end SDLC Process, Procedure and Tools.
- Trains the project team on the relevant procedures associated with different SDLC processes and Tools.
- Strong in Project Management tools like JIRA.
- Manage Project priorities based upon identified risks.
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