FIRST NAME Isaac

RESOURCE
LAST NAME De La Luz Garcia
RESUME
NATIONALITY Mexican

PROFILE SUMMARY

Over 4 years of experience in pharmaceutical environment with advanced experience in Computerized

Systems Validation and Equipment and Utilities Commissioning & Qualification. Possesses wide
knowledge of GxP Guidelines, 21 CFR Part 11, EU GMP Annex 11, ALCOA+ Data Integrity Principles,
ISPE GAMP guidelines and main FDA Guidance(s) for Industry. Perform the execution of a GxP and
ALCOA+ Data Integrity Assessment by directing critical business relevant conversations with client
leadership and internal stakeholders.
Self-motivated and directed, with the ability to work both independently and in a team-oriented,
collaborative environment. Good communication and interpersonal skills, capability to work
independently as well as in teams. Time management and multitasking abilities in a fast-paced,
deadline-driven environment. Good aptitude for critical thinking to include evaluation of ideas and
synthesizing information into insights.

EXPERTISE

Advanced experience on Computer System Validation Projects through the development/review of

validation plans, user requirements specifications, configuration and design specifications, risk
assessment reports, traceability matrixes, installation-operational-performance qualification protocols,
validation summary reports for laboratory systems, with focus on:
 Developing User Requirement Specifications (URS), Functional Requirement Specification (FRS),
Software Design Specification (SDS)
 Writing and Execution of Validation Protocols: Installation Qualification (IQ), Operational
Qualification (OQ) and Performance Qualification (PQ).
Advanced experience on Pharmaceutical Process Equipment Commissioning & Qualification
through development/review of validation plans, user requirements specifications, design qualification
protocols/reports, risk assessment reports, critical aspects verification plans, traceability matrixes,
verification protocols, installation-operational-performance qualification protocols and validation
summary reports, with focus ICH roles and ISPE GAMP Guidelines.

“I hereby authorize the use of personal data contained in my curriculum vitae in accordance with art. 13 of Legislative Decree 196/2003 and art. 13 GDPR 679/16.”
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EDUCATION

 Biotechnology Engineering, Political University of Cuautitlán Izcalli

JOB EXPERIENCES

2022-today PQE Group – Mexico City, Mexico

Consultant

2021-2022 Laboratorios Liomont SA de CV

Vaccine Manufacturing Supervisor

2021 Sanofi Aventis

Validation Engineer

2020-2021 Procter & Gamble

Validation Consultant

2020 Importadora y Manufacturera bruluart SA

Computer Systems Validation Engineer

2018-2020 Importadora y Manufacturera Bruluart SA

Parenteral Manufacturing Liquids Supervisor

2018 Importadora y Manufacturera Bruluart SA

Validation Analyst

LANGUAGES

Spanish Mother Language

English Fluent

DELIVERED SERVICES AT LABORATORIOS LIOMONT

 Supervision of COVID-19 vaccine manufacturing process

 Management and monitoring of the manufacturing program
 Monitoring of activities of the quality management system in the area
 Personnel management and training monitoring

DELIVERED SERVICES AT SANOFI AVENTIS

“I hereby authorize the use of personal data contained in my curriculum vitae in accordance with art. 13 of Legislative Decree 196/2003 and art. 13 GDPR 679/16.”
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  Preparation of protocols, reports, for qualification of equipment
 Monitoring and execution of validation to computerized systems

DELIVERED SERVICES AT PROCTER & GAMBLE

 Verification of Documentation for the validation of computerized systems

DELIVERED SERVICES AT IMPORTADORA Y MANUFACTURERA

BRULUART

 Computer Systems Validation Engineer

o Preparation of protocols, software validation reports
o Preparation of user requirements, design and functional specifications
o Preparation of procedures for generating software backups and user management
o Participation in the computerized systems validation implementation team within the
company
 Parenteral Manufacturing Liquids Supervisor
o Supervision of the manufacturing process of Injectable Liquids and Sterile Powders
o Management of the production program and coordination of activities to meet required
objectives
o Unionized personnel management
 Validation Analyst
o Preparation of protocols, reports, for the qualification of equipment and systems, as well
as process validation, cleaning validation
o Instrument Calibration

“I hereby authorize the use of personal data contained in my curriculum vitae in accordance with art. 13 of Legislative Decree 196/2003 and art. 13 GDPR 679/16.”
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