Validation Expert

Managed Services - Kosice, Malaysia

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Your profile / requirements

• Bachelor’s degree in Computer Science, Engineering, or Life Sciences; Master’s preferred
• 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
• Experience with validated systems such as SAP, CTMS, Veeva Vault, MES, LIMS, and eLN
• Familiarity with ITIL-based service operations and testing automation tools
• Strong documentation, communication, and stakeholder collaboration skills
• Motivation to improve global healthcare and deliver exceptional service
• Willingness to travel up to 20% and flexibility in working hours based on project needs

Tasks and responsibilities

• Ensure continuous, compliant operation of GxP-relevant computer systems under Managed Services.
• Lead and coordinate validation and re-validation efforts, maintaining audit-ready lifecycle documentation.
• Support change management, upgrades, migrations, and decommissioning while preserving validation state.
• Provide ongoing compliance support aligned with 21 CFR Part 11, Part 820, EudraLex, and GAMP5.
• Collaborate with client IT, Quality, and Regulatory teams to align on validation and compliance actions.
• Standardize and reuse validation templates, protocols, and procedures across systems and clients.
• Monitor regulatory developments and adapt validation strategies accordingly.
• Integrate validation with service processes such as incident management, CAPA, and change control.
• Operate within delivery methodologies like ITIL, Agile, DevOps, and Waterfall.
• Candidates must be willing and able to work according to Central European Time (CET) business hours

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