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GMP TECHNOLOGIES (S) PTE LTD

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IT System Administrator - CSV (Permanent)

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Discussion
  • Manage end-to-end system administration for all supported applications and infrastructure, including user access management, incident troubleshooting, issue resolution, and root cause analysis (RCA).
  • Support and progressively take ownership of digital project execution, including functional testing, User Acceptance Testing (UAT), system implementation, upgrades, go-live support, and post-implementation hypercare.
  • Support and lead activities across the Computer System Validation (CSV) lifecycle, including the preparation and review of User Requirement Specifications (URS), Functional Specifications (FS), Risk Assessments (RA), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), test management, and validation summary reports. Ensure compliance with GMP requirements and support internal and external audits, Corrective and Preventive Action (CAPA) management, and change control processes.
  • Coordinate with third-party vendors on system maintenance, technical issue resolution, and upgrade planning.
  • Provide Tier 2 and Tier 3 technical support to end users, ensuring timely resolution of system-related issues and minimal operational disruption.

Requirements

  • Bachelor's degree in Information Technology, Computer Science, Engineering, or a related field.
  • Minimum 3 years of experience supporting enterprise-grade manufacturing, laboratory, or related operational systems.
  • Proficiency in Windows Server administration, enterprise application management, and user access provisioning, modification, and revocation processes.
  • Hands-on experience with Microsoft SQL Server, including the ability to develop, execute, and troubleshoot basic to intermediate SQL queries for data retrieval, system troubleshooting, and issue investigation.
  • Working knowledge of GAMP 5, GMP data integrity requirements, ALCOA+ principles, 21 CFR Part 11, and EU GMP Annex 11, with an understanding of their application in regulated environments.
  • Basic understanding of API functionality, system integration concepts, and core networking principles, including TCP/IP, DNS, and VPN.

We regret that only shortlisted candidates will be notified.

GMP Technologies (S) Pte Ltd | EA License: 11C3793 | EA Personnel: Bautista Gia Grace De Guzman | Registration No: R23111973

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