Seeking a highly experienced Regulatory Affairs professional to manage regulatory activities for parenteral (injectable) products across the LATAM region.
Awareness on current Data Integrity requirements & cGMP requirements, Stability studies. Knowledgeable in handling OOS/OOT/Deviations and QMS (CAPA, CCP etc.) / LIMS Software.
Analysis of Raw material, Stability and Finished product samples, must have hands on experience of instruments like, HPLC, GC, UV, KF, ICPMS & IR etc., QC investigation and QMS.
Cliantha Research, a full-service Clinical Research Organization (CRO), is a leading provider of Clinical research services, based in Ahmedabad, India.