Development QA Executive - API

Job Description

Role & responsibilities Review of Analytical method validation, method transfer and method verification protocols & reports. Review of method development reports. Review of Stability & Holding Study analysis data. Review of equipment qualification /calibration/ validation reports (IQ, OQ, PQ) related to all analytical instruments. Should have knowledge on review of Specifications & Standard test procedures. Review of reference standard and impurity COAs and characterization data. Should have knowledge of GTI & Nitrosamines risk assessment. Responsible for issuance and archival of documents. Should have good knowledge of ICH guidelines, USP general chapters. Should have knowledge of QMS activity (Incidents, Change controls). Review of Empower and other analytical instruments audit trails. Responsible for maintaining GLP & GDP at the workplace. Excellent written and verbal communications skills. Preferred candidate profile