Note: The job is a remote job and is open to candidates in USA. United Consulting Hub is seeking an ambitious Junior Computerized Systems Validation (CSV) Analyst for its pharmaceutical and life sciences operations. The role supports the validation of software and digital infrastructure, ensuring computerized systems remain compliant, dependable, and aligned with regulatory frameworks.
Responsibilities
- Assist in validating critical computerized environments such as LIMS, ERP, SCADA, and MES platforms
- Draft, review, and execute core validation deliverables including URS, FS, DS, IQ, OQ, and PQ
- Ensure all systems adhere strictly to Good Manufacturing Practice (GMP) and 21 CFR Part 11 mandates
- Participate actively in technical risk assessments and overall validation planning
- Maintain rigorous documentation standards in compliance with Good Documentation Practices (GDP)
- Help prepare for and support internal audits and external regulatory inspections
- Coordinate smoothly with Quality Assurance, Information Technology, and engineering teams
- Handle change control requests, manage deviations, and support CAPA resolution processes
- Safeguard data integrity across all supported computerized systems and workflows
Skills
- Experience: 0–2 years
- • Foundational knowledge of GMP and GAMP guidelines alongside the core validation lifecycle (URS through PQ)
- • Direct familiarity with computerized systems validation and baseline data integrity concepts
- • Strong technical writing, analytical aptitude, and logical problem-solving abilities
- • Effective interpersonal communication skills paired with fundamental IT literacy
- • Exposure to industry software packages like LIMS, SAP, MES, or SCADA platforms
- • Working knowledge of ISO 9001 standards and broader GxP regulatory environments
- • Deep understanding of data integrity frameworks, particularly the ALCOA+ principles
- • Practical background via relevant validation, QA, or IT systems internships and projects
Benefits
- Remote work arrangement
Company Overview
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