Karunakar Reddy Pindukuru

Assistant Manager @Dr. Reddy's Laboratories

Hyderabad, IN

Oversee the end to end activities of the Microbiology Department.2. Overall responsibility of Microbiology Laboratory & compliance.3. Overall responsibility of Environmental monitoring and Water System compliance.4. Contribute to the equipment’s and instrument qualifications (IQ, OQ, PQ).5. Handling of Deviations, Change controls and excursions related to Microbiology.6. Water system implementation in (Microbial and Chemical) through Labware LIMS and Environmental monitoring program development in LIMS.7. Environmental monitoring (Passive and active air sampling, Surface sampling and Personnel gear sampling).8. Review and approval of manufacturing investigations for OOS, OOT and OOL.9. Review and approval of error rectifications in the documents.10. Review and responsible for the compliance of GMP documents in the shop floor.11. Preparation and review of SOP, s, STP, s, Protocols, URS and Reports review of monthly & annually water, Environmental monitoring trends reports. Biological indicators(Geobacillus steoro thermophiles) Sterility,GPT and Population county13. Isolation and Identification of microorganisms by BBL Crystal.14. Amenable for Growth promotion test and 10-100 cells preparation.15. Microbial analysis of water.Microbial Limit Test. Water Bacterial Endotoxin Testing by Gel Clot Method.Bio burden Test.17. Responsibility for Finished product and Raw materials Sterility Testing by Conventional and Closed Methods.18 Product (Injections) Bacterial Endotoxin Testing by Gel Clot Method.19. Microbial Limit Test.29. Biological indicators(Geobacillus steoro thermophiles) Sterility,GPT and Population county21. Growth Promotion Test.Culture maintains. Preparation of SOP, s and STP, s.

Sri Venkateswara University

M.Z.C

Sri Venkateswara University

M.Sc