Golla Parijatham

Assistant Manager @Biological E. Limited

Hyderabad, IN

Change control initiation, Deviation Management & CAPA points implementation.• Revision and preparation of SOP’s and STP’s in align with the guideline requirements.• Protocol and report preparation for validation of new tests and products.• Preparation of Isolate summary report annually for selection of predominant isolates observed in the plant.• Testing & Review of Isolation and identification in Vitek2 Compact equipment.• Preparation of Microbial Library for isolates observed in the production units• Plasmid retention and phenotype test for Harvest samples of recombinant strains (Pichia pastoris – Hepatitis-B & Covid19 products).• Disinfectant efficacy test for newly identified isolates in the plant.• Planning,testing and release of COA for various cell banks to check different parameters