Analytical Development Analyst
CurrentAnalytical Development Analysis with an emphasis on Raw Material.
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Katherine Bocardi is listed as P&D | Validação Analítica | Documentação Técnica | Assuntos Regulatórios | CMC e Internacional | Dossiê | DMF at Hypera, a with 4171 employees, based in São Paulo, Brazil. AeroLeads shows a matched LinkedIn profile for Katherine Bocardi.
Katherine Bocardi previously worked as Analytical Development Analyst at Hypera and Analytical Development Analyst at União Química Farmacêutica Nacional. Katherine Bocardi holds Postgraduate Degree, Regulatory Affairs With An Emphasis On Cmc And International from Cdpi Pharma.
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My journey is characterized by an unwavering pursuit of learning and excellence. I have a professional career focused on the pharmaceutical industry, with 6 years of experience. I am involved in the evaluation of DMFs (critical analysis of manufacturer specifications and the methodologies used), the preparation of impurity comparison protocols and synthesis routes, always adhering to ICH and ANVISA standards. I develop degradation protocols, reports, and analytical methodology development. My role requires a strong understanding of current regulations. I perform the review of technical documentation, including protocols and reports for analytical methodology validation, forced degradation studies, stability studies, and raw material analyses. I also prepare high-complexity technical justifications in compliance with regulatory agency standards.**Additional Skills:*** Dossier analysis with a focus on the analytical and regulatory aspects.* Emphasis on data integrity and compliance.* Collaboration with quality assurance to ensure adherence to necessary good practices.* Interpretation of ICH guidelines, DMFs (Drug Master Files), and Pharmacopoeias.* Proficiency in software such as OpenLab CDS, SE-Suite, Action, and LIMS systems (BS ONE).* Internal Auditor for 5S Management.
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Barueri - Alphaville
Analytical Development Analysis with an emphasis on Raw Material.
Guarulhos, São Paulo
Development and Validation Analyst of analytical methodologies for raw materials and medicines, according to RDC 166/2017 and RDC 31/2010.
Guarulhos-Sp
Quality control analyzes of raw materials and medicines.
Pouso Alegre E Região, Brasil
Performance analyst for pilot batches (liquids, solids and semi-solids). Use of chromatography equipment (HPLC and UPLC) – Empower 3.0 Waters software, dissolutor and UV/VIS spectrophotometer. Tests for content, content uniformity, dissolution, dissolution profile. Release of reports and calculation sheets.
Pró- Reitoria De Extensão (Proex)
Voluntaria
Brasil
Trabalho desenvolvido por 2 anos como Iniciação Científica registrada e Trabalho de Conclusão de Curso com aprovação pela banca de profissionais em Fisiologia da UNIFAL.
Other employees you can reach at hyperapharma.com.br. View company contacts for 4171 employees →
Liliane Silva Da Silva
Colleague at HyperaVila Velha, Espírito Santo, Brazil
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EN
Emerson Neves
Colleague at HyperaSalvador, Bahia, Brazil
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MQ
Maisa Quinta Silva
Colleague at HyperaGoiânia, Goiás, Brazil
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JL
Jacqueline Lima De Oliveira
Colleague at HyperaCuritiba, Paraná, Brazil
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DD
Daniella De Cássia Pinto
Colleague at HyperaSão José Dos Campos, São Paulo, Brazil
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GV
Guilherme Ventura Rondanin
Colleague at HyperaSão Paulo, Brazil
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MO
Mychelle Oliveira
Colleague at HyperaGoiânia, Goiás, Brazil
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PC
Paulo Cezar Bonfin
Colleague at HyperaPato Branco, Paraná, Brazil
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JD
Juliane Da Costa De Carvalho
Colleague at HyperaSão Paulo, Brazil
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AP
Alinijane Pereira
Colleague at HyperaGoiânia, Goiás, Brazil
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Postgraduate degree in analytical development and quality control in the pharmaceutical industry.
Activities and Societies: II Congresso Mineiro de Farmácia
Quick answers generated from the profile data available on this page.
Katherine Bocardi works for Hypera.
Katherine Bocardi is listed as P&D | Validação Analítica | Documentação Técnica | Assuntos Regulatórios | CMC e Internacional | Dossiê | DMF at Hypera.
Katherine Bocardi is based in São Paulo, Brazil while working with Hypera.
Katherine Bocardi has worked for Hypera, União Química Farmacêutica Nacional, Aché Laboratórios Farmacêuticos, Grupo Cimed, and Universidade Federal De Alfenas - Unifal-Mg.
Katherine Bocardi's colleagues at Hypera include Liliane Silva Da Silva, Emerson Neves, Maisa Quinta Silva, Jacqueline Lima De Oliveira, and Daniella De Cássia Pinto.
You can use AeroLeads to view verified contact signals for Katherine Bocardi at Hypera, including work email, phone, and LinkedIn data when available.
Katherine Bocardi holds Postgraduate Degree, Regulatory Affairs With An Emphasis On Cmc And International from Cdpi Pharma.
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