Job Responsibilities
* As a QA Validation Engineer, you will develop, implement, and execute URS, SIA, DQ, IQ, OQ, PQ, RV, and TM activities for mainly small scale equipment.
* You will develop, implement, and execute validation studies for cGMP-critical process systems to demonstrate compliance with cGMP, User, and Regulatory requirements.
* You will perform validation of systems in accordance with cGMP, cGLP, and company procedures.
* You will ensure that the Validated Status of systems in scope is in compliance with cGMP at all times.
* You will ensure projects are supported in conjunction with all required company and cGMP regulatory standards.
* You will keep current on emerging validation regulations and validation testing practices to meet or exceed cGMP requirements.
* You will provide technical assistance on current US FDA and EU validation requirements.
* You will generate validation documentation (protocols/reports) and provide assistance with the execution of protocols for systems in scope.
* You will be responsible for the validation documentation through approval and implementation.
* You will provide input in the review/assessment of changes to determine whether they impact the validated status and validation documentation, as appropriate.
Minimum Requirements
* Bachelor's or Master's degree in a scientific background.
* 2 - 4 years of experience in the qualification of small scale equipment (including related software).
* Knowledge of cGMP requirements in a regulated environment.
* Understanding of relevant quality and compliance regulations.
* Capable of troubleshooting validation issues.
* Good knowledge of quality management systems.
* Language: Dutch is required.
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