Job Description
Job Description:
Seeking an experienced CSV/CSA Consultant to support validation of SaaS and enterprise systems in a GMP environment. This role involves cloud system validation, equipment qualification, and ensuring compliance with FDA and global regulatory standards.
Roles & Responsibilities:
Requirements:
Seeking an experienced CSV/CSA Consultant to support validation of SaaS and enterprise systems in a GMP environment. This role involves cloud system validation, equipment qualification, and ensuring compliance with FDA and global regulatory standards.
Roles & Responsibilities:
- Validate SaaS and enterprise systems (Oracle Fusion Cloud ERP, serialization systems, eQMS, EBR).
- Perform CSA-based validation, release impact assessments, and system integrations.
- Execute IQ/OQ/PQ for manufacturing and lab equipment.
- Author and execute validation documents (URS, FRS, IQ/OQ/PQ, RTM, VSR).
- Ensure compliance with 21 CFR Part 11, GAMP 5, Annex 11, and data integrity.
- Support audits, inspections, change controls, deviations, and CAPAs.
Requirements:
...
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