GxP Validation Lead: Compliance & Continuous Improvement

Arcondis Group; Kuala Lumpur; On-site; MYR 90,000 - 130,000; Full time

Job summary

Arcondis Group seeks a Validation Expert to maintain validated state of GxP-relevant computer systems within long-term Managed Services engagements. You will coordinate validation activities for global clients and ensure audit-ready lifecycle documentation.

You will apply regulatory best practices, support changes and migrations while preserving validation. Collaboration with IT, Quality and Regulatory teams is essential, and knowledge of ITIL, Agile, DevOps is required.

Qualifications

• Bachelor's degree in Computer Science, Engineering or Life Sciences.
• 5+ years in computer system validation or IT compliance in pharma/medical tech.
• Strong knowledge of FDA 21 CFR Part 11, Part 820, GAMP 5.
• Experience with validated platforms (SAP, CTMS, Veeva Vault, MES, LIMS, ELN).

Responsibilities

• Maintain validated state of GxP-relevant computer systems in Managed Services.
• Lead and coordinate validation and revalidation activities and maintain audit-ready lifecycle documents.
• Support changes, upgrades, migrations and decommissioning while preserving validation.
• Provide compliance support with 21 CFR Part 11, Part 820, EudraLex and GAMP 5.
• Collaborate with client IT, Quality and Regulatory teams on validation actions.
• Standardise validation templates, protocols and procedures across systems.
• Monitor regulatory developments and adapt validation strategies.
• Integrate validation with incident management, CAPA and change-control.
• Work within ITIL, Agile, DevOps and Waterfall delivery approaches.

Skills

Documentation

Stakeholder collaboration

Service orientation

Travel readiness

Education

Bachelors in CS/Engineering/Life Sciences

Tools

SAP

CTMS

Veeva Vault

MES

LIMS

ELN

ITIL tools

Job description

Arcondis Group seeks a Validation Expert to maintain validated state of GxP-relevant computer systems within long-term Managed Services engagements. You will coordinate validation activities for global clients and ensure audit-ready lifecycle documentation.

You will apply regulatory best practices, support changes and migrations while preserving validation. Collaboration with IT, Quality and Regulatory teams is essential, and knowledge of ITIL, Agile, DevOps is required.