Job Description


Full Time Contract


Role: CSV Specialist

Location: % Onsite Manati, PR

Length of Contract: + Months Position Description

The CSV Specialist is responsible for managing and executing all activities related to Computer System Validation (CSV) throughout the full system lifecycle. This role ensures that computerized and automated systems—including manufacturing equipment, lab instrumentation, and IT infrastructure—comply with our Client CSV Standard Procedures , FDA CFR Part , and GAMP guidelines.

Responsibilities
  • Lifecycle Documentation: Author, review, and execute validation deliverables including Validation Plans, User Requirement Specifications (URS), Functional Requirements (FRS), Risk Assessments (FRA/DRA), IQ/OQ/PQ protocols, and Traceability Matrices (TM).

  • System Compliance: Perform CFR Part and Data Integrity (ALCOA+) assessment...

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