JANAINA D’ARC CARDOSO NUNES

+353 86 271 3184 – janainadarc@gmail.com – Skype: jana.cardoso10

linkedin.com/in/janaina-cardoso
Limerick - Ireland

OBJECTIVE
I seek a position in the Pharmaceutical area.

EDUCATION
2009 Bachelor's Degree in Pharmacy – Estacio de Sá University – BR
Currently PG in Regulatory Affairs (emphasis on CMC and international) – CPDI - BR

QUALIFICATIONS
● Vocational Qualification as Laboratory Technician.
● Comprehensive knowledge of current Good Manufacturing Practices (GMP) and Good Laboratory
Practices (GLP).
● Experience in Standard Operating Procedures (SOPs).
● Versed in compiling technical reports for submission to regulatory bodies.
● Yellow Belt certification - Lean Six Sigma.

KEY INTERPERSONAL SKILLS

● High level of adaptability and capacity to undertake multiple projects simultaneously.
● Team-player able to stimulate, motivate and generate optimum results.
● Proactive and detail-oriented professional who works well under stress and promptly meets deadlines.
● Flawless analytical skills and problem-solving abilities.

EMPLOYMENT HISTORY
Instituto Butantan Quality Control Analyst
11/2020 - 11/2021
Perform analysis on raw materials, serums and vaccines, water and stability studies.
Prepare, standardise and manage solutions, culture media, reference standards and
reagents.
Develop and review standard Operating Procedures (SOPs) and Analytical
Methodologies.
Compose and review study protocols and Method Validation reports.
Fill out documents according to current procedures.
Analyse results according to technical specifications.
Investigate specification results.
Participate in investigation of non-conformities.
Review of all documentation and logbooks to ensure accuracy and compliance with
cGMPs.
Understand and apply current legislation and compendial documentation so as to
carry out the analyses and fulfill requirements for approval of products and raw
materials.
Compliance with GLP, Health & Safety, Biosafety and Environment & Ethics
standards.

Blau Farmacêutica Quality Control Analyst

S.A. Production and review of Analytical Methods.
07/2020 - 11/2020
Elaboration and Assessment of Analytical Reports and Certificates.
Preparation and review of COAs.
Preparation, control and review of SOPs.
Planning and delivering procedural training sessions.
Eurofarma Pharmaceutical Equivalence Analyst
Laboratórios S.A. Drafting and review of Pharmaceutical Equivalence and Method Validation
06/2011 - 12/2019
documents.
Review of all documentation produced and compiled by the project team.
Ensuring laboratory SOPs were kept up-to-date and in a state of compliance.
Preparation, control and review of SOPs.
Review of all documentation and logbooks to ensure accuracy and compliance with
cGMPs.
Verification of analysis outside of specification guidelines.
Responsible for confirming the accuracy and integrity of data generated during
execution of analyses.
Planning and execution of Method Validations and analytical testing in accordance
with validation protocols.
Ensuring compliance with all safety and environmental requirements.
Verifying that standards required for execution of analyses are available and within
expiry date.

Max Pharma Quality Control Analyst

Co. Imp. de Insumos Analysing raw materials in accordance with Quality Standards and/or other approved
Farmacêuticos Ltda.
06/2009 - 03/2011 protocols.
Microbiological analysis of the raw material.
Environmental monitoring of raw material relationship booths.
Ensure that reagents and standards are clearly labelled and correctly stored
according to approved procedure and within their expiry date.

Bravet Lab. Ltda. Quality Control Analyst

08/2006 - 04/2009
Testing raw materials, intermediates drug product and stability of products in
accordance with Quality Standards and/or other approved procedures.
Ensure that reagents and standards are clearly labelled and correctly stored
according to approved procedure.
Keeping equipment in suitable status of cleanliness, calibration and qualification
according to pre-established guidelines.
Analysis of water used for the manufacturing of injectable products: pH, TOC,
conductivity, chlorides and endotoxin test.
Microbiological analysis of finished products and water used in the manufacturing
process.
Review of all documentation and logbooks to ensure accuracy and compliance with
cGMPs.

Equifarma Brasil Pharmaceutical Equivalence Internship

Serviços Ltda. Ensuring that reagents and standards are clearly labelled and correctly stored
11/2005 - 07/2006
according to approved procedure and within their expiry date.
Conducting analyses on characteristics of finished products such as: average weight
and volume, identification, hardness, friability, dissolution, disintegration, assay,
uniformity of content, Karl Fischer humidity, etc.
Writing of Pharmaceutical Equivalence and analytical validation documents.
ADDITIONAL RELEVANT COURSES AND SEMINARS
Specialization High Performance Liquid Chromatography (HPLC)
Laboratório Bravet Ltda. / Instituto Butantan
Seminar Bacterial endotoxins
Lonza Walkersville Inc.
Workshop Knowing U.S. Pharmacopeia and the correct use of Reference
Standards
USP Brazil

References available upon request.