QA Validation Engineer
Are you ready for the next step in your career? As a technical specialist in the Life Science sector, you work on technologies that improve lives. You play a key role in the development and optimization of systems for drug production, medical devices and biotechnology, for example.
Your work is crucial to the success of these projects.
Responsibilities
* As a QA Validation Engineer you develop, implement, and execute URS, SIA, DQ, IQ, OQ, PQ, RV, and TM activities for mainly small-scale equipment.
* You perform validation studies for cGMP-critical process systems to demonstrate compliance with cGMP, User, and Regulatory requirements.
* You carry out hands-on activities related to validation tasks.
* You validate systems where industry standards exist but require case-specific interpretation, in accordance with cGMP, cGLP, and company procedures.
* You ensure that validated systems remain compliant with cGMP at all times.
* You stay up to date on emerging validation regulations and testing practices to ensure compliance.
* You provide technical guidance on US FDA and EU validation requirements.
* You create and manage validation documentation (protocols and reports) and assist in their execution.
* You assess changes to determine their impact on validated status and related documentation.
Requirements
* 2-4 years experience in a Healthcare manufacturing environment.
* Experience with qualification of small scale equipment (including related software).
* Knowledge of cGMP requirements in a regulated environment.
* Understanding of relevant quality and compliance regulations.
* Knowledge of Quality Management Systems.
At STAR, your career is our focus. We connect you with challenging projects, offer personal guidance and create opportunities with clients you are excited about.
Together we make sure you get the most out of your career.
Get in touch with our Consultant Roosmarijn
Email
r.vandewater@star-specialists.com
Phone
+32 473501831
WhatsApp
+32 473501831