Assistant Manager - Computer System Validation (Cluster Office)

Position Overview

The position develops and designs system/data product solutions with the purpose of improving business efficiency and productivity for GMP and healthcare domain. You initiate the study and research of client business processes and requirements, information technology requirements, procedures or problems according to business needs. You analyse the feasibility of new systems and/or enhancements to existing systems. You will support daily IT operations for healthcare and GMP business process, ensuring governance and compliance are built into the operational process.

Role & Responsibilities

• Partner with business stakeholders to gather, analyse and translate business requirements into IT solutions and system specifications.
• Conduct business process analysis, gap assessments and feasibility studies to identify opportunities for process improvements and automation.
• Design and recommend technology solutions that maximise business value and operational efficiency.
• Manage requirements throughout the project lifecycle, including traceability, prioritisation and change management.
• Collaborate with development, testing and business teams to ensure solutions meet business requirements and quality standards.
• Support user acceptance testing (UAT), test planning, test execution and solution validation activities.
• Act as the primary IT contact for GMP operations and provide technical consultation to business stakeholders.
• Manage and support GxP applications and infrastructure, including system administration, access management, incident management and performance monitoring.
• Ensure GMP IT systems comply with applicable GxP regulations, SDLC standards, data integrity requirements and regulatory guidelines.
• Support audits, compliance activities, CAPA, change controls, risk assessments and documentation reviews.
• Coordinate with internal stakeholders, vendors and external partners to ensure timely issue resolution and continuous system availability.
• Drive continuous improvement initiatives to enhance system reliability, compliance and operational effectiveness.

Requirements

• Relevant degree in Computer Science, Information Technology, Engineering or related discipline.
• At least 4–8 years of relevant experience in IT operations, business analysis or solution delivery.
• Experience supporting GxP/GMP systems within biotechnology, pharmaceutical, cell therapy or life sciences environments.
• Familiarity with regulatory requirements such as HSA, FDA, EMA, 21 CFR Part 11 and Annex 11.
• Strong stakeholder management, analytical and problem-solving skills.
• Experience working in matrix or shared-services environments will be advantageous.

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