Note: The job is a remote job and is open to candidates in USA. United Consulting Hub is seeking an entry-level Computerized System Validation Analyst to support the validation of computerized systems used in pharmaceutical and life sciences environments. The role is responsible for preparing validation documentation, supporting compliance and risk activities, collaborating with cross-functional teams, and maintaining system validation and data integrity practices.
Responsibilities
- Assist in the validation of computerized systems such as LIMS, ERP, SCADA, and MES
- Prepare and execute 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 planning, and validation lifecycle activities
- Maintain proper documentation in accordance with Good Documentation Practices (GDP)
- Assist with internal audits, regulatory inspections, and compliance activities
- Collaborate with QA, IT, Engineering, and business teams
- Support change control, deviation, and CAPA processes
- Support data integrity assessments and computerized system compliance
Skills
- • Basic knowledge of GMP, GAMP 5 , and the computerized system validation lifecycle ( URS, IQ, OQ, PQ )
- • Familiarity with computerized systems, validation concepts, and data integrity principles
- • Strong documentation, analytical, organizational, and problem-solving skills
- • Good communication skills with basic IT and system knowledge
- • Familiarity with systems such as LIMS, SAP, MES, and SCADA
- • Knowledge of ISO 9001 and GxP-regulated environments
- • Understanding of data integrity principles such as ALCOA+
- • Internship or academic project experience in CSV, validation, QA, or IT systems
Benefits
- Location: Remote
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