Lupin Limited
Designation : Executive
Function : QA
Functional Area : Analytical QA
Job Role Summary : Review of TDS of Environmental monitoring, Microbiology tests, BET & Bioburden tests, Review of SOPs
Job Profile :
- 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.
- Review of TDS of Bacterial Endotoxin Test, Bioburden of Manufacturing samples.
- Review of Environmental monitoring TDS of Drug Product Manufacturing Facility.
- To review the Microbiology related SOPs /EOPs/ GTPs/STPs.
- To perform investigation of OOS, OOL, Deviation, Laboratory incidents related to Quality Control.
- Review of sterility TDS of Manufacturing samples.
- Review of SVPC (Sub visible Particle count).
- Review of water TDS reports.
- Review of LIMS Biological indicator module and documents related BI qualification.
- To perform SAP related transactions as per authorization.
Job Requirements :
- 4 to 5 years work experience in QA, Microbiology QC
Work / Job Experience : 4-5 Years
Type of Experience : QA, Analytical QA, Microbiology QC
Academic Qualifications :
- Post Graduation in Biotechnology or Microbiology
