QUALITY CONTROL ANALYST

GenIbet is a cGMP biopharmaceutical CMO (Contract Manufacturing Organization) offering highly specialized microbial, cell culture and viral process development and cGMP manufacturing services to research groups, biotech and pharma companies.
GenIbet’s core activity is the manufacture and supply of materials for use in early stage drug development, pre-clinical studies and cGMP manufacturing for Phase I and II clinical trials.
Quality Control Mission.
Manage, coordinate and supervise GenIbet’s quality control activities and processes, ensuring commitments are met within the established quality standards, and supporting GenIbet’s clients on building the therapies of the future.
Main Responsibilities and Activities.
a) Physiochemical and microbiological analysis specifically required for raw materials approval, ensuring compliance with established procedures and current Good Manufacturing Practice (cGMP), and the related records and reports’ elaboration; b) Perform the routine monitoring, namely environmental and water for injectables (WFI) control, according to the procedures in place, and ensure the preparation and availability of the related reports; c) Preparation and revision of Quality Control procedures and reports; d) Preparation, execution and reporting of protocols for the implementation of new methods of analysis or procedures; e) QC activities planning according to specific processes.
If you want to join us and be part of a unique Team that works on a daily basis to make a positive difference in people life´s, send your application.