The posting
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



