Monitor timeline, deliverables, risks, and dependencies
Follow up with stakeholders to ensure closure of actions
Prepare project updates for management
Coordinate preparation and completion of required project and validation documents
Ensure documentation is properly organized, version controlled, and reviewable
Support GAMP 5 / CSV / audit-related documentation where applicable
Track traceability, deviations, actions, and final closure
Help maintain project discipline and compliance readiness
Key Scope:
Manage project delivery for internal digital systems
Coordinate users, vendor, and management
Monitor timeline, scope, risk, and issue resolution
Ensure proper documentation and compliance support
Support validation lifecycle such as URS, FSD, IQ, OQ, PQ, UAT, traceability, and summary closure
Support audit readiness and controlled change implementation
Job Requirements:
Bachelor's Degree in Information Technology, Computer Science, Information Systems, Project Management, or other related discipline
Candidates with relevant project management and system implementation experience may also be considered even if academic background is from a related technical or business field
Minimum 3-5 years experience in project coordination, project management, or system implementation
Experience in internal business system projects, manufacturing systems, quality systems, or regulated environments is an advantage
Experience coordinating across multiple departments and external vendors is preferred
Exposure to validation, compliance documentation, or controlled documentation practices is an added advantage
Understanding of project lifecycle, documentation control, and structured delivery practices
Familiarity with digital systems such as web-based applications, business systems, MES, WMS, ERP, or quality systems is preferred
Basic understanding of system testing, UAT, issue tracking, and change control
Awareness of GAMP 5, CSV, FDA, or regulated system documentation is an advantage
