ValidationSupports the project leader in coordinating the project team to achieve the defined project deliverables in relation to validation:
- Lists together with the project leader and project engineers which validation activities need to take place and in what sequence.
- Clarifies the overall project validation strategy to the entire project team.
- Provides a continuous overview of the status of all validation activities and advises the project leader in relation to impact on project timeline.
- Continuously follows up the predefined validation strategy and adjusts / escalates if needed.Writes and manages the VPP/VPR together with the project lead.
- Watches over good validation practices (verification, validation master plan, change management, .) and the quality of the different deliverables.
- Facilitates general validation activities (system risk assessment, cGMP-review). Point of contact related to validation in the project.
- Coaches the project engineers related to verification/validation/CRF/QRM in the project.
- Bridges between Engineering, Site Compliance, SME, System Owner throughout the project.
- Clarifies the overall project validation strategy during internal and external project audits.
SchedulingSupports the project leader in coordinating the project team to achieve the defined project time line:
- Assist the project lead to compose, consolidate and update a timeline with different milestones, which must be endorsed by the team.
- Develop and maintain accurate and complete detailed project schedule file in MS Project. Monitor continuously the project schedule file for integrity and completeness.
- Keep the project team informed regarding the progress of all project tasks and activities and provide input for the management communication & reporting.
- Alert the project team and Project Management of problems/conflicts relating to the execution of project tasks and activities.
- Assist the project lead to define and evaluate project risks and to propose a mitigation plan. Document this process in the Project Risk Management document.