- Kuala Lumpur Federal Territory Malaysia
Sepenuh Masa Validation Expert Jobs, in Arcondis Group Kuala Lumpur - Maukerja
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Overview
The Validation Expert maintains the validated state of GxP-relevant computer systems within long-term Managed Services engagements. Working with global clients, the role applies regulatory best practices, coordinates validation activities and supports continuous improvement within a structured service-delivery model.
Key Responsibilities
Qualifications
The Validation Expert maintains the validated state of GxP-relevant computer systems within long-term Managed Services engagements. Working with global clients, the role applies regulatory best practices, coordinates validation activities and supports continuous improvement within a structured service-delivery model.
Key Responsibilities
- Maintain the continuous and compliant operation of GxP-relevant computer systems within Managed Services.
- Lead and coordinate validation and revalidation activities and maintain audit-ready lifecycle documentation.
- Support changes, upgrades, migrations and decommissioning while preserving the validated state of systems.
- Provide compliance support aligned with 21 CFR Part 11, 21 CFR Part 820, EudraLex and GAMP 5.
- Collaborate with client IT, Quality and Regulatory teams on validation and compliance actions.
- Standardise and reuse validation templates, protocols and procedures across systems and clients.
- Monitor regulatory developments and adapt validation strategies where required.
- Integrate validation activities with incident management, CAPA and change-control processes.
- Work within ITIL, Agile, DevOps and Waterfall delivery approaches.
Qualifications
- Bachelor’s degree in Computer Science, Engineering or Life Sciences.
- Strong documentation, communication and stakeholder-collaboration skills.
- Service-oriented approach and motivation to support improved healthcare outcomes.
- Flexibility in working hours based on project needs.
- Willingness to travel up to 20%.
- At least 5 years of experience in Computer System Validation, IT compliance or quality assurance.
- Strong knowledge of FDA 21 CFR Part 11 and Part 820, GAMP 5 and quality management systems in pharmaceutical or medical technology environments.
- Experience with validated platforms such as SAP, CTMS, Veeva Vault, MES, LIMS and electronic laboratory notebooks.
- Familiarity with ITIL-based service operations and testing-automation tools.
- Master’s degree in Computer Science, Engineering, Life Sciences or a related field.
Peringatan Penting
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