Opportunity Description
Job Description:
The SQA is the quality authority for regulated software initiatives, ensuring that all changes, releases, and deployments comply with Client System Life Cycle (SLC) requirements, Computer System Validation (CSV) expectations, and global regulatory standards (e.g., 21 CFR Part 11, GAMP5).
The role balances compliance, delivery enablement, and risk-based decision-making, enabling predictable and audit ready releases.
Responsibilities:
"No release without validated evidence and approved SLC compliance.”
SLC & Validation Governance:
The SQA is the quality authority for regulated software initiatives, ensuring that all changes, releases, and deployments comply with Client System Life Cycle (SLC) requirements, Computer System Validation (CSV) expectations, and global regulatory standards (e.g., 21 CFR Part 11, GAMP5).
The role balances compliance, delivery enablement, and risk-based decision-making, enabling predictable and audit ready releases.
Responsibilities:
"No release without validated evidence and approved SLC compliance.”
SLC & Validation Governance:
- Ensure mandatory SLC documentation is created, reviewed, and approved.
- Act as the final quality gate before deployment.
- CSV Oversight:
- Ensure end to end traceability (requirements → code → test → evidence).
- Oversee deviations, impact assessments, and CAPA.
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