Senior GxP Validation & Compliance Analyst

21 DexCom Malaysia Sdn Bhd; Seberang Perai; On-site; MYR 180,000 - 240,000; Full time

Job summary

21 DexCom Malaysia Sdn Bhd, a global leader in CGM, seeks a Senior Validation Specialist to drive GxP validation across IT/OT for APAC operations. You will lead CSV, CSA, IQ/OQ/PQ, and related validation deliverables, while ensuring regulatory compliance.

You will partner with IT, OT, Quality and Manufacturing teams to shape validation strategies, risk assessments, and documentation across the SDLC, delivering auditable processes that support regulatory objectives.

Qualifications

• Bachelor's degree in Engineering, Quality, Computer Science, Life Sciences, or a related discipline.
• Minimum of 5 years of direct experience validating manufacturing systems and regulated computer systems.
• Proven experience validating enterprise systems such as MES, ERP, QMS, EDMS, LIMS, and manufacturing automation including PLC/SCADA.
• Strong understanding of GxP processes and FDA/ISO regulatory requirements.
• ASQ SQE certification and medical device experience desirable.

Responsibilities

• Serve as SME for validation and compliance of GxP systems (MES/ERP/QMS/SCADA/PLCs).
• Lead validation activities: CSV, CSA, IQ/OQ/PQ/PPQ, Test Scripts, and risk-based validation.
• Provide QA/QC guidance for IT/OT systems ensuring regulatory compliance and inspection readiness.
• Perform GxP risk assessments at system, functionality, and data-element levels.
• Advise IT/OT/Quality/Manufacturing on validation strategies and risk mitigation.
• Ensure compliance with FDA 21 CFR Part 11, ISO 13485, EU MDR and related regs.
• Develop and maintain validation deliverables across the SDLC.
• Communicate progress and risks to Dexcom teams and leadership.

Skills

Regulatory compliance

Validation leadership

Risk assessment

Quality systems

Cross-functional collaboration

Communication

Education

Bachelor's degree in Engineering/Quality/CS/Life Sciences

Tools

Microsoft Office

Excel

Minitab

Database applications

Job description

21 DexCom Malaysia Sdn Bhd, a global leader in CGM, seeks a Senior Validation Specialist to drive GxP validation across IT/OT for APAC operations. You will lead CSV, CSA, IQ/OQ/PQ, and related validation deliverables, while ensuring regulatory compliance.

You will partner with IT, OT, Quality and Manufacturing teams to shape validation strategies, risk assessments, and documentation across the SDLC, delivering auditable processes that support regulatory objectives.