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