[Remote] CSV Analyst Entry Level
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 computerized system validation and compliance in pharmaceutical and life sciences environments. The role involves preparing validation documentation, supporting audits and compliance activities, and collaborating with cross-functional teams on system lifecycle, data integrity, and quality processes.
Responsibilities
- Assist with the validation of computerized systems such as LIMS, ERP, SCADA, and MES
- Prepare and execute validation documentation, including URS, FS, DS, IQ, OQ, and PQ
- Support compliance with Good Manufacturing Practice (GMP) and 21 CFR Part 11
- Assist with risk assessments, validation plans, and system lifecycle activities
- Maintain accurate documentation in accordance with Good Documentation Practices (GDP)
- Support internal and external audits, inspections, and compliance activities
- Collaborate with QA, IT, Engineering, and other cross-functional teams
- Assist with change control, deviation, and CAPA activities
- Support data integrity, access controls, and computerized system compliance
Skills
- • Basic understanding of Good Manufacturing Practice (GMP), Good Automated Manufacturing Practice (GAMP), and the validation lifecycle
- • Familiarity with validation deliverables such as URS, IQ, OQ, and PQ
- • Basic knowledge of computerized systems and data integrity principles
- • Strong documentation, analytical, and problem-solving skills
- • Good communication skills with basic IT and system knowledge
- • Familiarity with systems such as LIMS, SAP, MES, or SCADA
- • Knowledge of ISO 9001 and GxP-regulated environments
- • Understanding of data integrity principles, including ALCOA+
- • Internship, academic project, or practical exposure to validation, QA, CSV, or IT systems
Company Overview
Company H1B Sponsorship