Quality Assurance Executive - Analytical and Microbiology

Job Description

1. Review of Environmental Monitoring TDS (Viable and Non-Viable) of Mammalian Manufacturing Facility (Phase-1, Phase-2, Phase-3, Phase-4), Microbial Manufacturing Facility, Drug product manufacturing and Warehouse area-2.
2. Review of TDS of Bacterial Endotoxin Test, Bioburden of Manufacturing samples.
3. Review of Environmental monitoring TDS of Drug Product Manufacturing Facility.
4. To review the Microbiology related SOPs /EOPs/ GTPs/STPs.
5. To perform investigation of OOS, OOL, Deviation, Laboratory incidents related to Quality Control.
6. Review of sterility TDS of Manufacturing samples.
7. Review of SVPC (Sub visible Particle count).
8. Review of water TDS reports.
9. Review of LIMS Biological indicator module and documents related BI qualification.
10. To perform SAP related transactions as per authorization.

Work Experience

4 to 5 years work experience in QA

Education

Competencies