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1. Technical & Deployment Expertise

• Knowledge of global CSV, PMM and risk mitigation.
• Understanding of infrastructure (servers,networks, databases) in GxP contexts.
• Experience in CLM, Serialization, global QA and QC Lab systems

2. Risk Management

• Ability to assess risk impacts anddefine rollback plans.

3. Testing & Validation

• Experience drafting CSV test cases for IT systems implementation.
• Support DIOP qualification of PT equipment
• Execute and document the testing case result and assess deviation if any.
• Ensure the system functionalities fulfill the business requirements.
• Ensure the system to follow global Cybersecurity requirements.

4. Stakeholder Coordination

• Lead technical alignment meetings with cross-function teams (e.g., IT, QA, vendors, local and global).
• Collect user feedback and translate it into actionable fixes.

5. Project Management
· Ensure deliverables meet FDA 21 CFR Part 11/EU GMP standards.
· Maintain project schedules, track tasks/activities, and report issues to stakeholders.