Quality Control Analyst

About Xedev Xedev is a dynamic Contract Development & Manufacturing Organization (CDMO), specialized in pharmaceutical formulation and process development. We support pharmaceutical companies worldwide in developing solid dosage forms, with strong expertise in drying, agglomeration, and coating processes, including our core technology spray drying. As an independent development partner, we act as the bridge between customer ideas and robust pharmaceutical products. Our combination of scientific know-how, process expertise, and hands-on experience makes Xedev an attractive partner for companies looking to accelerate their development. From our modern facility in Zele (Belgium), we continue to grow and innovate – and we are looking for talented QC analyst to strengthen our team. Your role as QC analyst As a QC analyst, you play a central role within our scientific pharmaceutical product development teams. Together with the QC Manager, you are developing and validating analytical methods together with performing routine analyses. You act as the scientific reference point within the team, combining hands-on expertise with the ability to guide and inspire colleagues. Your responsibilities include: · Perform routine and non-routine QC analyses using liquid chromatography techniques (HPLC/UPLC), including assay, impurity, and dissolution testing. · Conduct analytical method development and optimization for LC-based methods to support product development and QC needs. · Lead or support method intake and method transfer activities from R&D or external laboratories into the QC environment. · Perform method verification and validation in accordance with ICH guidelines and internal procedures. · Execute analytical testing in compliance with GMP, approved methods, specifications, and SOPs. · Evaluate, interpret, and accurately document analytical results in laboratory notebooks and electronic systems. · Troubleshoot chromatographic and method-related issues, including system suitability failures and method performance deviations. · Participate in OOS, OOT, deviation, and CAPA investigations, providing analytical and technical input. · Support routine maintenance, calibration, and qualification of LC instrumentation. · Ensure data integrity in line with ALCOA+ principles and regulatory expectations. · Provide analytical support during internal and external audits and regulatory inspections. · Contribute to continuous improvement initiatives within the QC laboratory. Profile · Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or a related field. · Minimum of 3 years of relevant experience in a GMP-regulated QC or analytical development environment. · Strong hands-on experience with HPLC/UPLC, including method development and troubleshooting. · Practical experience with method transfer/intake and validation or verification activities. · Solid understanding of GMP, ICH guidelines, and pharmaceutical quality systems. · Experience with chromatography data systems (e.g. Empower). · High attention to detail and strong documentation skills. · Ability to work independently and collaboratively within cross-functional teams. · Fluency in Dutch is required together with good written and verbal communication skills in English. Why join us? At Xedev, you will: Work in a fast-growing, innovative CDMO at the heart of the pharmaceutical industry. Be part of a collaborative and inspiring team where your expertise truly makes an impact. Expand your knowledge and advance your career through challenging projects, trainings, and conferences. Contribute directly to the development of medicines that improve lives worldwide. Receive a competitive salary and benefits package, reflecting your skills and contribution, with opportunities for personal and professional growth. Ready to make an impact? Send your CV and motivation letter to elien@xedev.com.