To provide the service as Project business analyst role to bridge technical, business, and regulatory needs, the following two aspects are required.
Main Tasks:
1. Deployment Planning & Coordination
• Collaborate in developing the System Deployment Plan, including timelines, rollback strategies, and role assignments.
• Coordinate with IT, business users, and vendors to ensure compliance with Change Control procedures.
2. Configuration & Validation
• Verify that the production environment matches the validated test environment
• Ensure the IT infrastructure and devices are qualified (e.g., servers, databases, peripheral devices).
• Support Installation Verification (IV) and Acceptance Testing to confirm GxP compliance.
• Assist in DIOPQ execution, validating system performance in the live environment.
• Document test results and address deviations (e.g., user-reported issues).
3. User Access & Security Controls
• Review and configure Role-Based Access Control (RBAC) for production, adhering to the least-privilege principle.
• Ensure Audit Trail functionality is enabled and tested.
4. User Training & Go-Live Support
• Conduct end-user training on production system operations (e.g., e-signatures, audit trail queries).
• Provide Hypercare support post-launch to resolve initial issues.
5. Documentation & Compliance Closure
• Finalize deployment deliverables (such as URS, DS, FS, Test Plans, Test Cases, Test Reports, Deployment Report, Training Records, etc.) for the Validation Package.
• Ensure all activities pass QA review before Go-Live approval.
Main Requirements:
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 and define 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.