Job Description

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