Description
One of the world`s largest Pharmaceutical and Biotechnology companies requires a Dutch and English speaking Validation Officer - IT systems to work in their large manufacturing and research facility in Southern Holland. This is an interim position, initially for a 5 month period.You will be responsible for the implementation of the validation strategy and its implementation and reporting within in a team. The work associated with these fields:
Qualification and validation (computer based) manufacturing and laboratory systems, methods and processes.
-The work must be in accordance with current EU GMP and FDA guidelines and the internal organisation regulations implemented.
-Ensure various validation processes.
- Assess the impact of changes,
-Ensure requalification, support and implementation of validations.
-Supporting internal and external parties in the implementation of the validations and reports.
Job requirements
-Minimum HBO working and thinking.
- Experience in the pharmaceutical, medical, chemical or food industry.
-Thorough knowledge of validation in accordance with EU GMP and FDA guidelines.
-Knowledge of and experience with IT systems / application management.
- Knowledge of and experience with GAMP / GMP.
-Thorough knowledge of the principles and implementation of validation and qualification.
-Good command of Dutch and English.
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Competencies
-Accuracy
-Persuasion
-Project management
-Quality Focused