Description

You will lead computer system validation efforts for regulatory systems within the pharmaceutical industry.

Responsibilities

• Guide project teams in delivering documentation based on project type and SDLC application.
• Manage multiple GxP projects and prioritize tasks based on identified risks.
• Train team members on policies, end-to-end SDLC processes, procedures, and tools.
• Facilitate technical interaction between project teams and business stakeholders.
• Perform root cause analysis for critical issues and implement preventive measures to reduce defects.

Required Skills

• 10+ years of experience in Computer System Validation of regulatory systems including RIM, REMS, Publishing, and eCTD.
• Expertise in SDLC deliverables including Requirements Specification, User Stories, Criticality Assessment, and Test Plans.
• Deep knowledge of 21 CFR Part 11, FDA guidance, and industry standards such as GAMP.
• Proficiency in documenting Validation Plans, Design Documentation, Risk Assessments, Validation Strategies, and Requirement Trace Matrices.
• Strong understanding of Risk-Based Approaches.
• Experience using JIRA for project management.
• Ability to interpret business rules and requirements for software development documentation.

Preferred Skills

• Any Graduate degree.

Key Skills

Education

Any Graduate