Software Quality Assurance (SQA) � GxP / CSV

Responsibilities

• "No release without validated evidence and approved SLC compliance."
• Ensure mandatory SLC documentation is created, reviewed, and approved.
• Act as the final quality gate before deployment.
• Ensure end-to-end traceability (requirements → code → test → evidence).
• Oversee deviations, impact assessments, and CAPA.
• Confirm release readiness and validation completion.
• Verify adherence to client SLC, customer SOPs, and quality standards.
• Proactively escalate quality, compliance, and regulatory risks.
• Guide teams on right-sized documentation (avoid over/under validation).
• Validate documentation effort estimates and validation planning.
• Partner with delivery to enable compliance without execution delays.
• Ensure validation readiness ahead of major releases and go lives.
• Provide visibility on quality health, risks, and trends.
• Ensure continuity through strong documentation and knowledge transfer.
• Block releases due to compliance or validation gaps.
• Accept or challenge risk justifications.

Key Success Measures

• Zero critical audit/review observations attributable to SQA gaps.
• On time releases with approved SLC & validation artifacts.
• High first-time right documentation quality.
• Early identification and mitigation of compliance risks.