QC Process Specialist Data & Digitalization

Job Description SummaryAs a QC Process Specialist Data & Digitalization, you ensure that data, computer systems, and digital processes within QC function reliably, efficiently, and compliantly. You connect QC users, system owners, IT, and project teams, translating user needs into practical and user-friendly solutions. In doing so, you safeguard data integrity and work according to GMP, quality, and EHS requirements. You coordinate the implementation and improvement of QC systems and digital workflows and support daily QC operations regarding data and system issues. Additionally, you lead or support digitalization and improvement projects through which you further standardize, simplify, and make processes less error-prone. This role is based in Eindhoven.Job Description

• Coordinating QC data, system, and digitalization activities and monitoring priorities, progress, dependencies, and risks;
• Leading and supporting digitalization and improvement projects, including Change Controls, CAPAs, deviations, and risk assessments;
• Translating QC processes and user needs into functional requirements, digital solutions, and clear management agreements;
• Coordinating changes, qualification, validation, implementation, and management of QC computer systems and digital workflows;
• Safeguarding data integrity and compliance with GMP, quality, and EHS requirements throughout the entire lifecycle of systems and data;
• Supporting and training QC users and collaborating with QA, IT, production, engineering, system owners, and other stakeholders to standardize processes and continuously improve.

• HBO or WO (Bachelor's or Master's) degree in Life Sciences, analytical chemistry, microbiology, computer science, engineering, or a similar field;
• Relevant experience within QC, laboratory automation, data management, or GMP computer systems. For example, you currently work as a Super User, Subject Matter Expert, or Administrator for Chromeleon or a similar system;
• Good knowledge of QC processes, data flows, data integrity principles, and working within a GMP-regulated environment;
• Experience with implementation, qualification, and/or validation of computer systems and the preparation of associated technical and quality documentation;
• Experience with project-based working, Change Controls, CAPAs, deviations, risk assessments, and process improvement; experience with LEAN is a plus;
• Good command of Dutch and English and strong analytical, organizational, and communicative skills; experience with QC software such as Chromeleon and/or LabX and a (radio)pharmaceutical environment is a plus.

Relocation Assistance Provided: No