Jefferson S. - QA Specialist

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Tallinn, Estonia

Experience

Apr 2025 - Present

9 months

Estonia

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

Jan 2022 - Mar 2025

3 years 3 months

Brazil

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)

Jan 2017 - Jan 2022

5 years 1 month

Brazil

Analytical R&D Manager

Vitamedic Pharmaceutical Industry Ltd

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)

Jul 2016 - Jan 2017

7 months

Analytical Development Supervisor

Vitamedic Pharmaceutical Industry Ltd

Supervised validation, stability, and dissolution studies
Analytical method development and validation for new products support and post registration (Dissolution, Forced Degradation Studies, others)

Nov 2015 - Jul 2016

9 months

Senior Analytical Development Analyst

Fresenius Kabi

DMF analysis to support supplier qualification
Analytical method development and validation for new products support

Aug 2014 - Nov 2015

1 year 4 months

Analytical Researcher

Brainfarma/Hypermarcas

Developed methods and performed full API characterization to develop new association (Incremental innovation)

Aug 2011 - Aug 2014

3 years 1 month

Analytical Development Analyst

Brainfarma

Developed and transferred HPLC/UPLC methods

Aug 2010 - Jul 2011

1 year

Pharmaceutical Equivalence & Validation Analyst

Teuto Brasileiro/Pfizer

Method validation and pharmaceutical equivalence (PE studies)

Oct 2007 - Aug 2010

2 years 11 months

Senior QC Analyst

Teuto Brasileiro

QC using HPLC, UV, IR, titration, potentiometry

May 2006 - Oct 2007

1 year 6 months

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.