QC Scientist - Testing

Job Summary: • Experiences in IPC, finished products (DS/DP) testing. • Experience in HPLC & GC operations & troubleshooting, CE-SDS, cIEF, cell based potency, ELISA based qualification, Karl Fischer Titrator, Total Organic Carbon (TOC) testing, Solo VPE/UV-Vis Spectrophotometer • Keep detailed records of inspections, test results, and deviations. Prepare reports summarizing findings for management. • Analyze defects, identify root causes for process deviations, and work with production teams to implement corrective and preventive actions. • Ensure products conform to internal standards, industry regulations, and safety requirements. • Develop and update quality control procedures, standards, and protocol Requirements: • Bachelors Degree in biotech or biopharmacy • 3 Years of relevant working experience • A good understanding of the overall view of drug development process. • A thorough understanding of the principles and management of cGMP compliance, and strong quality minds. • Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoieas. • Comprehensive knowledge in IND/IMPD, NDA and ANDA filing