Computer System Validation (CSV) Specialist

Job Description:
The CSV Specialist is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements. This role involves working closely with IT, Quality Assurance, and business stakeholders to validate new and existing systems, document validation evidence, and support audits and inspections.

Responsibilities:

Knowledge on FDA Guidance's and industry Standards.

Develop and execute validation plans, protocols (IQ/OQ/PQ), and reports for computer systems.

Assess and document system requirements, risk assessments, and user requirements specifications (URS).

Review and approve system design, configuration, and test documentation.

Ensure compliance with regulatory requirements (, FDA CFR Part , GAMP , EU Annex ).

Manage change control and deviation management processes for validated systems.

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