GxP Validation Lead — Life Sciences IT Compliance

ARCONDIS AG / GmbH; Malaysia; On-site; MYR 80,000 - 110,000; Full time

Job summary

ARCONDIS AG / GmbH is seeking a Consultant Digitalization of Customer Engagement in Malaysia. The role focuses on ensuring the compliant operation of GxP computer systems, leading validation efforts, and supporting compliance with regulations.

Ideal candidates will have a Bachelor’s degree and over 5 years of experience in IT compliance. Familiarity with FDA regulations and experience with validated systems are essential. Flexibility in hours and willingness to travel are required.

Qualifications

• 5+ years of experience in computer system validation, IT compliance, or quality assurance.
• Strong knowledge of FDA regulations (21 CFR Part 11, 820), GAMP5, and QMS in pharma/MedTech.
• Willing to travel up to 20% based on project needs.

Responsibilities

• Ensure continuous, compliant operation of GxP-relevant computer systems.
• Lead and coordinate validation and re-validation efforts with documentation.
• Support change management and compliance aligned with regulations.

Skills

GxP computer systems operation

Validation efforts coordination

Compliance support

Stakeholder collaboration

FDA regulations knowledge

Education

Bachelor’s degree in Computer Science, Engineering, or Life Sciences

Master’s degree (preferred)

Tools

SAP

CTMS

Veeva Vault

MES

LIMS

eLN

Job description

ARCONDIS AG / GmbH is seeking a Consultant Digitalization of Customer Engagement in Malaysia. The role focuses on ensuring the compliant operation of GxP computer systems, leading validation efforts, and supporting compliance with regulations.

Ideal candidates will have a Bachelor’s degree and over 5 years of experience in IT compliance. Familiarity with FDA regulations and experience with validated systems are essential. Flexibility in hours and willingness to travel are required.