AmatsiSEPS, a subsidiary of Amatsigroup, is a company dedicated to drug product development of drug candidates for third parties (CRO) and focusses on difficult to formulate drugs that are in preclinical, phase I or phase II clinical development. The company offers a full suite of drug development services encompassing preclinical development, preformulation development, formulation development, analytical development, dosage forms development, scaling-up and clinical trial manufacturing of drug candidates (NCE & NBE).
For our site in Ghent (Belgium) we have an open position for a QC Analyst.
- You perform Quality Control activities according to instructions, procedures and protocols in compliance with the GMP principles and the Quality Management System.
- You validate analytical methods to support the quality control and release of drug products for use in clinical trials.
- You plan and perform Quality Control analyses.
- You plan and perform ICH compliant stability studies.
- You support the preparation of the applicable protocols and reports.
- You accurately report, document and review the analytical test results.
- You support the maintenance, calibration and qualification of the analytical equipment.
- Professional Bachelor degree in biomedical laboratory technology, chemistry or pharmaceutical sciences with a minimum of 5 years relevant professional experience.
- Experience in a regulated Quality Control laboratory and experience with pharmaceutical analytical techniques (HPLC/UPLC, Dissolution, KF, Particle sizing, etc.) is a must.
- You are punctual and are able to work independently after a training in matters entrusted to you.
- You have experience with MS Office. Experience with Empower is a real asset.
- You are flexible, problem solving and quality minded.
- You are fluent in Dutch and English (written and spoken).
We offer a varied and challenging job with a permanent contract combined with an attractive salary package.