The Project Validation Coordinator is member of the Engineering Quality & Systems team and supports the project lead in coordinating the project team to achieve the defined project deliverables in relation to validation.
* Composes and consolidates the overall validation project plan/report and clarifies the validation strategy to the project team, management and inspectors
* Continuously follows up the predefined validation strategy, adjusts and/or escalates if needed and provides overview of the status and potential impact on project timeline
* Coaches the project engineers related to validation and quality systems and watches over good validation practices and the quality of the different deliverables
* Facilitates and documents quality system risk assessment activities
* Provides input for management communication & reporting
* Bridges between Engineering, Quality Projects, STS/LA, SME's and System Owners
* Functions as subteamlead Validation within the project team charter
* Supports the project lead in coordinating the project team to achieve the defined project time line
* Composes, consolidates and maintains the general project schedule file to keep the overview of all milestones towards the completion of the project
* Monitors continuously this overall project schedule file and keeps the project team informed regarding the progress and alerts problems/conflicts relating to the execution of project tasks and interrelations of project activities
* Assists the project lead to define and evaluate planning risks and mitigation plan
* Provides input for management communication & reporting
Profile
* A Master degree in a Scientific discipline (Engineering, Bio-engineering, Pharmacy, ...)
* Minimum of 3 years of experience in the pharmaceutical industry
* Knowledge of Validation
* Knowledge of Quality Management Systems
* Knowledge of Regulatory
* Knowledge and experience as audit spokes person
* Specific training and skills
* Strong organizational skills and structured approach
* High level of social and communication skills
* Fluent in Dutch and English