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CSV L1 & L2 Support

Fresher   Bangalore   21 Jul, 2025
HARJAI COMPUTERS PRIVATE LIMITED
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT Services & Consulting
Functional AreaApplication Programming / Maintenance
EmploymentTypeFull-time

Job Description

    CSV L1 Support (Level 1)The CSV L1 Support Engineer acts as the first line of defense to ensure validated systems remain compliant and operational. This role involves basic troubleshooting, documentation support, and compliance monitoring under GxP guidelines.Key Responsibilities:Incident Management: Log, track, and resolve basic technical issues related to validated systems. Compliance Monitoring: Monitor systems to ensure operation within validated parameters and escalate any deviations. Documentation Support: Assist in maintaining SOPs, validation protocols, and change control records. Backup Recovery: Monitor and support daily backup operations (e.g., Veritas NetBackup L1 tasks). Server Support: Provide L1 support for server-related issues and escalate complex issues to L2. Communication: Provide timely updates to users and maintain professional communication during incident resolution.Required Skills:Hands-on experience with CSV principles, GxP compliance, and validation practices.Working knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5 Guidelines, and GxP Standards.Strong communication, documentation, and issue escalation skills.Mandatory experience in Empower Waters software.CSV L2 Support (Level 2)The L2 CSV Support Engineer provides in-depth technical and compliance support for validated systems. This role focuses on system-level issue resolution, validation documentation management, and coordination with QA and L3 teams to ensure ongoing GxP compliance.Key Responsibilities:System Validation: Validate system updates or patches to ensure compliance is maintained. Documentation Management: Review, maintain, and update validation documentation (IQ/OQ/PQ, test scripts, traceability matrices). Issue Investigation: Troubleshoot and investigate system issues affecting validated processes; perform root cause analysis and implement corrective actions. GxP Compliance: Ensure GxP, GLP, and 21 CFR Part 11 compliance during system maintenance, upgrades, and operations. Team Collaboration: Work closely with QA and IT teams to resolve escalated issues and coordinate with L3 for unresolved problems. System Support: Provide L2 support for validated systems including servers, applications, and backup tools (e.g., Veritas NetBackup). Audit Support: Support internal/external audits by providing technical and compliance documentation. SOPs & Change Control: Create and manage SOPs, change control records, and compliance logs.Education:Bachelors degree in Computer Science, Information Technology, Engineering, or related field.

Keyskills :
computer system validationgamp21 cfr part 11

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