Role DescriptionThe research analyst QC is responsible to develop & validate analytical methods to obtain reliable and robust release testing procedures. Furthermore, the research analyst is involved in non-routine analyses to support investigations as well as the support of submission –related activities for new product introductions into the production department. Taking into account the experience with complex product testing it is considered that the Research analyst Complex drug product may act as key-expert in trouble-shooting analytical challenges with this type of products.
ResponsibilitiesYour responsibilities as a QC Analyst are:
- Perform complex testing; - Development, transfer, validation, verification and/or remediation of analytical methods; - Writing of protocols & reports; - Maintain adherence to corporate policies and appropriate regulations through actions and decisions; - Active participation in advanced problem solving, root cause analysis, troubleshooting, interpretation/consultation, verification of quality and test results discussions; - First-line Troubleshooting of laboratory equipment, aides in maintenance and certification of test instruments and apparatus to ensure compliance; - Active participation in changes or act as change owner as part of continuous improvement;
RequirementsThe requirements are:
- Bachelor degree in analytical chemistry/pharmacy or equivalent experience; - Knowledge and familiarity with the use of Pharmacopoeia methods; - A strong analytical oriented mindset; - Experience with working in a pharmaceutical environment; - Experience with analytical methods for complex drug products (e.g containing liposomes, proteins, microparticles) is a preference; - Experience with UPLC, CD, PSD, FFF is a preference; - Good knowledge of Pharmaceutical quality systems and production processes; - Team player, but able to work independently without minimal guidance; - Strong can-do mentality;
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Diana Prieto Reyes.