Thayla Melo Email & Phone Number

Montreal, Qc, Ca

Região Metropolitana De Montreal, Quebec, Canadá

São Paulo, São Paulo, Brasil

Novartis is a Swiss and one of the largest pharmaceutical companies in the world. São Paulo site (in Brazil) is specialized in sterile eye drops. I was approached in April 2019 to validate bioburden methods and support quality control routine.Achievements:- 9 transfers of sterility methods accomplished in 6 months;- Development of new bioburden tests;- Validation support for Indianapolis site.Routine:- Validation management such as planning, purchase of inputs, elaboration of protocols and reports, tests execution, and implementation of new methods.- Technical support for the team and management of the microbiological laboratory and other areas, such as Regulatory Affairs, Quality, Production and Engineering.- Daily tests: water analysis, microbial count of in-process and raw material products, pathogen research, sterility test, support to dosing test, microbial identification (Vitek MS and morphology), bioindicator counting, bioindicator analysis, growth promotion and assay diffusion antibiotics.- Investigation of Out-of-Specification Results using tools such as 5 whys, Ishikawa, and 5W2H.- Knowledge of E-Sops, LIMS, Infinity and Minitab systems

São Paulo, São Paulo, Brasil

AG3 is a Brazilian company specialized in provision of consulting services for pharmaceutical industries. I was approached to validate disinfectants for the Microbiological Laboratory cleaning.

Guarulhos, São Paulo, Brasil

Allergan is an American pharmaceutical that acquires, develops, manufactures and markets brand name drugs and medical devices in the areas of medical aesthetics, eye care, central nervous system, and gastroenterology. Guarulhos site is specialized in sterile and non-sterile eye drops.Achievement:- Routine organization of microbial identification, releasing results on due time.Routine:- Daily analisys: microbiological tests of process water, drinking water, products, raw material, endotoxin, and bioindicators, in addition to environmental monitoring, microbial identification by microscopy, automated tests (Vitek 2), and biochemical tests.- Reading and interpretation of results for releasing products, and interface with Pharmaceutical Technology and Manufacturing sectors.- Opening, investigating and closing deviations by the Track Wise system, using tools such as 5 Whys and Ishikawa.- Media Fill and Media Hold monitoring accompaniment for process improvement.- Member of the Fire Brigade

São Paulo, São Paulo, Brasil

Routine:- Microbiological analysis in cosmetics, inputs for cosmetics and chemical industries, process water and water for human consumption.- Evaluating the effectiveness of a preservative system by challenge test techniques- Analysis of bacteriostatic activity by Halo of Inhibition- Validation of microbiological methodology by inactivation of a preservative system- Identification of microorganisms by Gram stain and biochemical tests

Specialization In Applied Microbiology To Health And Industry

Bachelor Of Biological Sciences, Sciences