Jefferson (Luiz fonseca da) S.
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
- BMR creation
Technical Manager
EPHAR
Led Pharmaceutical Equivalence, QC, and Analytical Development
Managed 80-person team across 3 divisions
Conducted analytical validations, stability, degradation, dissolution
Oversaw project budgets and performance indicators
Projects:
KPI system, analytical documentation program, client communication plan (in progress)
Analytical R&D Manager
Vitamedic Indústria Farmacêutica LTDA
- Oversaw all analytical projects for registration/post-registration
- Implemented LIMS and new R&D lab infrastructure
- Led Nitrosamines and Portfolio Harmonization programs
- Risk management (ICH Q3D, USP <232>/<233>)
- Analytical method development and validation for new products support (Dissolution, Forced Degradation Studies, others)
Analytical Development Supervisor
Vitamedic Indústria Farmacêutica LTDA
- Supervised validation, stability, and dissolution studies
- Analytical method development and validation for new products support and post registration (Dissolution, Forced Degradation Studies, others)
Senior Analytical Development Analyst
Fresenius Kabi
- DMF analysis to support supplier qualification
- Analytical method development and validation for new products support
Analytical Researcher
Brainfarma/Hypermarcas
- Developed methods and performed full API characterization to develop new association (Incremental innovation)
Analytical Development Analyst
Brainfarma
- Developed and transferred HPLC/UPLC methods
Pharmaceutical Equivalence & Validation Analyst
Teuto Brasileiro/Pfizer
- Method validation and pharmaceutical equivalence (PE studies)
Senior QC Analyst
Teuto Brasileiro
- QC using HPLC, UV, IR, titration, potentiometry
Chemical Analyst
Genoma Laboratory
- Stability testing of pharmaceutical products
- Release tests for QC
- Method validation
Summary
Experienced QA and Analytical Development Specialist with over 19 years in the pharmaceutical industry, focusing on GMP compliance, analytical R&D, regulatory strategies, and quality systems.
Proven leadership in managing cross-functional teams and laboratory operations.
Strong knowledge of EU GMP, ICH guidelines, method validation, and quality risk management.
Seeking to contribute technical and strategic expertise to international pharmaceutical organizations.
Languages
Education
State University of Goiás
Master's in Organic Synthesis · Organic Synthesis · Brazil
State University of Goiás
B.Sc. in Chemistry · Chemistry · Brazil
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