Join a forward-thinking organization where your expertise will contribute to the critical validation of processes in a highly regulated environment. You will play a key role in ensuring compliance with industry standards and supporting streamlined operations.
We are looking for a dedicated professional to fill the role of
Validation Specialist
. The ideal candidate is detail-oriented, possesses a solid understanding of compliance regulations, and is enthusiastic about maintaining high-quality standards.
* You handle the development, implementation, and execution of URS, SIA, DQ, IQ, OQ, PQ, RV, and TM activities.
* You perform validation of systems, utilizing industry precedence and interpreting standards in accordance with cGMP, cGLP's, and relevant procedures.
* You ensure that the validated status of process systems in scope is continuously compliant with cGMP.
* You support projects following all required regulatory standards.
* You stay informed on emerging validation regulations and practices to meet or exceed cGMP requirements.
* You generate and assist with validation documentation (protocols/reports) using the Kneat paperless validation tool.
* You provide input regarding changes that may impact validated status and documentation.
What are we looking for?
* You have 2-4 years of experience in the pharmaceutical sector and GMP environment.
* You possess knowledge of
cGMP
requirements in a regulated setting.
* You have an understanding of relevant quality and compliance regulations.
* You are capable of troubleshooting validation issues effectively.
* Experience with validation of Clean Steam Generator systems and parts washers is an advantage.
* You are proficient in
English
and
Dutch
.