Description

You will manage Computer System Validation and quality processes within GxP application environments.

Responsibilities

• Guide project teams on applicable SDLC deliverables based on project type and category.
• Document and oversee SDLC deliverables including Requirements Specifications, User Stories, Test Plans, and Risk Assessments.
• Facilitate technical interaction between project teams and business stakeholders.
• Train team members on policies, end-to-end SDLC processes, and validation tools.

Required Skills

• 3-7 years of experience in Computer System Validation, Quality Management, or Business Analysis in GxP areas.
• Hands-on experience with tool validation for ServiceNow, Jira, or Automation tools.
• Strong understanding of 21 CFR Part 11 and Risk-Based Approaches.
• Proficiency in creating Requirement Trace Matrices and Validation Summary reports.
• Experience managing project priorities based on identified risks.
• Working knowledge of the Software Development Life Cycle (SDLC).
• Ability to manage deliverables including Criticality Assessments and Design Documentation.

Preferred Skills

• Any Graduate degree.

Key Skills

Education

Any Graduate