懂CSV,要出文档的,行业背景不局限。
英语要求:需要单独跟老外开会,属于能英文讨论的
To provide the service as Project business analyst role to bridge technical, business, 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, role assignments.
•Coordinate with IT, business users, 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 devices are qualified (e.g., servers, databases, peripheral devices).
•Support Installation Verification (IV) Acceptance Testing to confirm GxP compliance.
•Assist in DIOPQ execution, validating system performance in the live environment.
•Document test results address deviations (e.g., user-reported issues).
3. User Access & Security Controls
•Review configure Role-Based Access Control (RBAC) fproduction, adhering to the least-privilege principle.
•Ensure Audit Trail functionality is enabled 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.) fthe Validation Package.
•Ensure all activities pass QA review before Go-Live approval.
•Finalize deployment deliverables (such as URS, DS, FS, Test Plans, Test Cases, Test Reports, Deployment Report, Training Records, etc.) fthe Validation Package.
•Ensure all activities pass QA review before Go-Live approval.
Requirements:
1. Technical & Deployment Expertise
•Knowledge of global CSV, PMM risk mitigation.
•Understanding of infrastructure (servers, networks, databases) in GxP contexts.
•Experience in CLM, Serialization, global QA QC Lab systems
2. Risk Management
•Ability to assess risk impacts define rollback plans.
3. Testing & Validation
•Experience drafting CSV test cases fIT systems implementation.
•Support DIOP qualification of PT equipment
•Execute document the testing case result 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 global).
•Collect user feedback translate it actionable fixes.
5. Project Management
• Ensure deliverables meet FDA 21 CFR Part 11/EU GMP standards.
• Maintain project schedules, track tasks/activities, report issues to stakeholders.
Requirements:
1. Technical & Deployment Expertise
•Knowledge of global CSV, PMM risk mitigation.
•Understanding of infrastructure (servers, networks, databases) in GxP contexts.
•Experience in CLM, Serialization, global QA QC Lab systems
2. Risk Management
•Ability to assess risk impacts define rollback plans.
3. Testing & Validation
•Experience drafting CSV test cases fIT systems implementation.
•Support DIOP qualification of PT equipment
•Execute document the testing case result 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 global).
•Collect user feedback translate it actionable fixes.
5. Project Management
• Ensure deliverables meet FDA 21 CFR Part 11/EU GMP standards.
• Maintain project schedules, track tasks/activities, report issues to stakeholders.