Posted:6 hours ago|
Platform:
Work from Office
Full Time
- Coordinate release planning for validated systems
- Ensure compliance with GxP, FDA 21 CFR Part 11 and other regulatory standards- Manage validation deliverables such as IQ/OQ/PQ protocols, traceability matrices, and risk assessments- Collaborate with QA, CSV, and IT teams to align release activities with validation and testing schedules- Maintain release documentation, including change control records, release notes, and audit trails- Conduct release readiness reviews and ensure proper approvals before deployment- Facilitate go/no-go decisions with stakeholders based on validation status and risk impact- Track and report release metrics, deviations, and CAPAs related to deployment activities- Support audits and inspections by providing release-related evidence and documentation- Strong knowledge of CI/CD pipelines, branching strategies, and version control- Proven stakeholder management and communication skills
Agilisium
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