Note: The job is a remote job and is open to candidates in USA. United Consulting Hub is seeking a motivated CSV Analyst to support the validation of computerized systems in pharmaceutical and life sciences environments. The role focuses on ensuring system compliance, reliability, data integrity, and adherence to regulatory requirements.

Responsibilities

• Assist in validation of computerized systems such as LIMS, ERP, MES, and SCADA
• Prepare and execute validation documents (URS, IQ, OQ, PQ)
• Ensure compliance with GMP, GAMP, and 21 CFR Part 11 requirements
• Support validation planning, risk assessments, and change control activities
• Maintain validation documentation in line with GDP standards
• Assist with audits, inspections, deviations, and CAPA processes
• Collaborate with QA, IT, and cross-functional teams
• Support data integrity and regulatory compliance initiatives

Skills

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, Engineering, or a related field
• 1–2 years of experience or internship exposure in CSV, QA, IT, or validation environments
• Basic understanding of validation lifecycle (URS, IQ, OQ, PQ), GMP, and GAMP principles
• Familiarity with LIMS, SAP, MES, or SCADA systems
• Knowledge of GxP regulations, ISO standards, and ALCOA+ data integrity principles
• Strong documentation, analytical, and communication skills
• Ability to work independently in a remote environment

Company Overview

Company H1B Sponsorship