The department is responsible for the realization of Capital Projects for the production of Aseptic Drug Products, starting from the conceptual design phase up to the full validated operational phase.
The Project Validation Coordinator is member of the Engineering Quality & Systems team within the Puurs Engineering department.
* The Project validation coordinator is responsible for: the coordination of validation and planning activities of Capital Projects
EDUCATION, TRAINING AND/OR EXPERIENCE
* DegreeA Master degree
* Formal educationScientific discipline (Engineering, Bio-engineering, Pharmacy, ...)
* Experience requiredMinimum of 3 years of experience in the pharmaceutical industry
* Knowledge of Validation
* Knowledge of Quality Management Systems
* Experience for preferenceKnowledge of Regulatory Requirements
* Knowledge and experience as audit spokes person
* Specific training and skillsStrong organizational skills and structured approach
* High level of social and communication skills
* Fluent in Dutch and English
PRINCIPAL ACCOUNTABILITIES
* 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 and other departments
* 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.