Bharat Bongale Email and Phone Number

• Has complete understanding and knowledge of Method suitability and routine, Sterility Testing by membrane filtration and direct inoculation, Microbial limit testing (formulated product, raw materials and packaging components), Antimicrobial effectiveness testing, Antibiotic microbial assays for potency determination, Container closure integrity testing, Bacterial endotoxin testing, Quality control qualification of biological indicators and Isolator Sterility Testing (IST)• Evaluate purified and deionized water for bioburden, endotoxin and TOC testing as per USP requirements• Perform all job functions in compliance with cGMPs and maintain accurate logbooks, complete documentation and prepare APR's and COA's as required• Participate in project teams and perform other duties,write and review SOPs, deviations, CAPA, change controls and technical investigations and reports as assigned.• Developing, updating and implementing policies and procedures to ensure quality assurance in the company as per ICH and cGMP-FDA guidance document• Preparing and directing preparation of dossiers and cGMP files to be submitted to various regulatory agencies• Identifying and investigating cGMP related issues, deviations, conducting root cause analysis and timely resolution of the issues• Conducting internal audits and implementing corrective actions wherever necessary• Assessing, recommending and formulating training session at regular intervals for employees of all departments

• Conducted compliance verifications and investigations of potential health hazards and other violations of the Food and Drugs Act and its Regulations in response to complaints• Monitored /assessed corrective actions of regulated parties (Mandatory Medical Device Problem Reports) for its compliance and risk assessment subject to the Medical Device Regulations• Evaluated and assessed specific complaints and provided recommendation for appropriate action according to the risks• Identified and analysed emerging trends in health safety or environmental issues pertaining to medical device • Enforced corrective actions as needed in instance of non-compliance• Coordinated and communicated activities with other government departments (OGDs),Regions and other Health Canada Directorate such as MHPD• Collated, prepared, approved and published medical devices recalls and safety alerts on Healthy Canadians web site

• Developed project management tools, worked with other government departments, other CFIA groups and stakeholders to ensure program delivery• Contributed in the development and implementation Food Safety and other commodity specific guidelines• Was a contributing member of the product tracking team working on the development of a list of commodities, helpful for border inspection

• Worked with level-II and level-III viruses like Adeno and Rabies virus• Proficiencies in mammalian cell culture, handling of viruses, maintained mammalian cell tissue cultures like VERO, MNA, and HEK293• Performed tests such as: Titrating viral stocks, and running cell-based viral assays, Rabies diagnostic tests like C-ELISA, virus neutralization assay, SDS-PAGE ,Western blott, Immunoprecipitation, Propagation of rabies virus ERA (Evelyn Rokitniki Abelseth strain) and determination of its titer

• Participated in planning and discussions, research projects and product evaluation to assess safety and efficacy of biologics• Evaluated drug for its safety, potency and delivery system in beef cattle• Performed molecular assays like DNA isolation and quantification, hybridization of pGEM vectors, DNA finger printing-PCR, PFGE, RFLP ,Western blott, and ELISA • Performed microbiological testing such as sterility, cell based assays, antimicrobial resistance assays, bacterial endotoxin and bioburden on raw and final products, and LAL test

• Produced large-scale growth of bacterial cells for recombinant protein production and purification• Carried out protein isolation, purification and separation methods by using resin columns and SDS-PAGE, PCR • Cloning and purification of proteins• Prepared and performed QC tests on various diagnostic medias, reagents, buffers and water and maintained laboratory equipment