Senior Validation & QA Systems Analyst

Dexcom Inc.; Kuala Lumpur; On-site; MYR 120,000 - 200,000; Full time

Job summary

Dexcom Inc. in Penang, Malaysia, seeks a Sr Business Systems Analyst to drive validation of enterprise and manufacturing systems. You will lead CSV/CSA activities, ensure GxP compliance, and partner with IT, OT, Quality and Manufacturing to optimize cost accounting and data integrity within an Oracle EBS framework.

The role emphasises risk-based validation, regulatory alignment, and delivering end-to-end validation deliverables across the SDLC with collaboration from regional teams.

Qualifications

• Bachelor's degree in Engineering, Quality, Computer Science or Life Sciences.
• Minimum 5 years validating manufacturing systems in regulated industries.
• Experience with CSV/CSA, 21 CFR Part 11 and risk-based validation.

Responsibilities

• Lead validation activities for ERP/MES/QMS in a regulated environment.
• Develop Validation Plans, Protocols, Risk Assessments and SOPs.
• Collaborate with IT, OT, Quality, Manufacturing teams and leadership.
• Ensure compliance with FDA/ISO requirements and inspection readiness.

Skills

CSV/CSA

GxP compliance

Validation strategy

Cross-functional leadership

SDLC documentation

Regulatory knowledge

Education

Bachelor's degree in Engineering/Quality

Tools

MS Office

MiniTab

Database applications

Job description

Dexcom Inc. in Penang, Malaysia, seeks a Sr Business Systems Analyst to drive validation of enterprise and manufacturing systems. You will lead CSV/CSA activities, ensure GxP compliance, and partner with IT, OT, Quality and Manufacturing to optimize cost accounting and data integrity within an Oracle EBS framework.

The role emphasises risk-based validation, regulatory alignment, and delivering end-to-end validation deliverables across the SDLC with collaboration from regional teams.