Jefferson (Luiz Fonseca Da) Silva
QA Specialist
Experience
QA Specialist
Interchemie Werken de Adelaar Eesti
- Drafting and reviewing SOPs (EU GMP Annex 1)
- Performing investigations of deviations and events (EU GMP Chapter 8)
- Supporting audit readiness and CAPA implementation
- Creation of batch manufacture review (EU GMP Annex 1)
Laboratory Manager
EPHAR
Led laboratory of pharmaceutical equivalence, QC, and analytical development
Managed 80-person team across 3 divisions
Conducted projects with method development and analytical validations, stability studies, forced degradation studies, dissolution and other techniques (HPLC, UHPLC, GC, spectrophotometers, ICP, LC-MS, titration)
Conducted pre-formulation projects (XRD, TGA, DSC, MS, particle size)
Oversaw project budgets and performance indicators
Cost management
KPI system
Analytical documentation program
Client communication plan
Analytical Development Manager
Vitamedic Indústria Farmacêutica LTDA
- Oversaw all analytical projects for registration and post-registration
- Analytical method development and validation for new product support (dissolution, stability, indicated methods, forced degradation studies, others)
- Pre-formulation (XRD, TGA, DSC, MS, particle size)
- Led nitrosamines and portfolio harmonization programs
- Implemented LIMS and new analytical R&D lab infrastructure
- Risk management (ICH Q3D, USP <232>/<233>)
- Dissolution method development
Analytical Development Supervisor
Vitamedic
- Supervised validation, stability, and dissolution studies
- Analytical method development and validation for new product support and post-registration (dissolution, forced degradation studies, others)
Senior Analytical Development Analyst
Fresenius Kabi
- DMF analysis to support manufacturer qualification
- Analytical method development and validation for new product support (UHPLC, HPLC, GC, dissolution profile)
Analytical Researcher
Brainfarma/Hypermarcas
- Developed methods and performed full API characterization to develop new associations (incremental innovation)
- Developed and transferred HPLC and UPLC methods
Senior QC Analyst
Teuto Brasileiro
- QC using HPLC, UV, IR, titration, potentiometry
- Method validation and pharmaceutical equivalence studies
Chemical Analyst
Genoma Laboratory
- Stability testing of pharmaceutical products
- Release tests for QC
- Method validation
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Pharmaceutical (16.5 years) and Healthcare (0.5 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Quality Assurance (16.5 years), Research and Development (13 years), Product Development (11.5 years), and Project Management (3 years).
Summary
Experienced QA and Analytical Development Specialist with over 19 years in the pharmaceutical industry, focusing on GMP compliance, analytical Development, regulatory strategies, and quality systems. Proven leadership in managing cross-functional teams and laboratory operations. Strong knowledge of EU GMP, ICH and ANVISA`s guidelines, method validation, and quality risk management. Seeking to contribute technical and strategic expertise to international pharmaceutical organizations.
Analytical Development Manager or QC Manager
Languages
Education
State University of Goiás
Master in Organic Synthesis · Organic Synthesis · Brazil
State University of Goiás
Bachelor of Science in Chemistry · Chemistry · Brazil
Profile
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