Anca Oancea

Coordinating and coaching the chemists and the lab technicians in the QC laboratory. Reporting and investigating deviations and out-of-specification results in collaboration with QA department. Participation, as required, in internal and external audits of the facility (authorities and third party partners). Involved in the method validation and in the transfer of analytical methods from/at other laboratories. Issuing quality specifications for raw materials, primary and secondary packaging materials.

Routinely perform analytical tests for pharmaceutical products using specific techniques (HPLC, GC, UV-VIS, IR) according to GMP/GLP guidelines. Troubleshooting and solving analytical issues in the laboratory. Contribute in the implementation of new technologies where appropriate, by development and validation of test methods for pharmaceutical products. Involved in preparing for audits from different authorities (FDA).