Note: The job is a remote job and is open to candidates in USA. United Consulting Hub is seeking an entry-level CSV Analyst to support the validation of computerized systems used in pharmaceutical and life sciences environments. The role assists with validation documentation, regulatory compliance, risk assessments, audits, change control, data integrity, and collaboration with cross-functional stakeholders.
Responsibilities
- Support validation activities for computerized systems such as LIMS, ERP, SCADA, and MES
- Assist in preparing and executing validation documents including URS, FS, DS, IQ, OQ, and PQ
- Ensure compliance with Good Manufacturing Practice (GMP) and 21 CFR Part 11
- Support risk assessments, validation plans, and traceability activities
- Maintain accurate validation documentation in accordance with Good Documentation Practices (GDP)
- Assist with internal and external audits and regulatory inspections
- Collaborate with QA, IT, Engineering, and business stakeholders
- Support change control, deviation, CAPA, and periodic review activities
- Assist in ensuring data integrity and computerized system compliance
Skills
- Experience: 0–2 years
- • Basic knowledge of Computer System Validation (CSV), Good Manufacturing Practice (GMP), and Good Automated Manufacturing Practice (GAMP 5), with an understanding of the computerized system validation lifecycle (URS, IQ, OQ, PQ)
- • Familiarity with computerized systems, validation documentation, and data integrity principles
- • Strong documentation, analytical, organizational, and problem-solving skills
- • Good written and verbal communication skills with basic IT knowledge
- • Familiarity with systems such as LIMS, SAP, MES, or SCADA
- • Knowledge of ISO 9001 and GxP-regulated environments
- • Understanding of ALCOA+ data integrity principles
- • Internship, academic project, or hands-on exposure to CSV, validation, QA, or IT systems
Company Overview
Company H1B Sponsorship