Ensure software projects follow SDLC processes, quality standards, and compliance requirements for non-GxP applications. Provide quality oversight and guidance throughout the project lifecycle.
Key Responsibilities:
- Review project deliverables to ensure compliance with SDLC standards and quality requirements.
- Provide quality coaching, risk assessment, and feedback to project teams.
- Review requirements, test scripts, defects, traceability matrices, and change controls.
- Author or approve Compliance Plans, Compliance Summary Reports (CSR), and other quality documents as required.
- Support defect management, root cause analysis, and continuous process improvements.
- Monitor project quality metrics and help teams avoid rework through early quality assurance activities.
Skills Required:
- SDLC knowledge
- Quality Assurance and Testing knowledge
- Risk Management
- Compliance and Documentation Review
- Solid communication and stakeholder management skills