Maria Guadalupe Flores Estrada

Sc. M. trained in biotechnology and bioingenering with experience in Project development, I have the ability to work independently or as part of a team. I have strong communication skills developed from my extensive experience both in research, as well as in the Pharmaceutical and Biotech industry.

Project Engineer

Bayer · Full-time Apr 2021 - Present 

• Budget, manage and coordinate the CAPEX of the projects from the projection of the Business case, procurement strategy, plan and request for resources, execute the monthly planning and control of expenses until the capitalization of the assets.
• Perform the role of expert for the design, construction and implementation of projects and transfers, ensuring the correct definition of the technology to be implemented considering the impact on facilities, equipment, services, security, etc.
• Coordinate and supervise the multidisciplinary team ensuring project compliance in time, quality, scope and costs.
• Develop, coordinate and direct the project with the leaders and external providers (meetings, generation and delivery of documentation, AR, URS, FS, risk analysis, change controls, PEMO, cleaning protocols, commissioning, qualification, and validations, authorizations, etc.) during all phases of the project until delivery to the end user.• Budget, manage and coordinate the CAPEX of the projects from the projection of the Business case, procurement strategy, plan and request for resources, execute the monthly planning and control of expenses until the capitalization of the assets. • Perform the role of expert for the design, construction and implementation of projects and transfers, ensuring the correct definition of the technology to be implemented considering the impact on facilities, equipment, services, security, etc. • Coordinate and supervise the multidisciplinary team ensuring project compliance in time, quality, scope and costs. • Develop, coordinate and direct the project with the leaders and external providers (meetings, generation and delivery of documentation, AR, URS, FS, risk analysis, change controls, PEMO, cleaning protocols, commissioning, qualification, and validations, authorizations, etc.) during all phases of the project until delivery to the end user.

Skills: Project Management · Agile Project Management · Project Planning · Risk Management · Risk Assessment · Pharmaceutics

Analytical CoordinatorAnalytical Coordinator

Sanofi-Aventis Farmaceutica · Jul 2020 - Apr 2021 

Schedule stability analysis, MP for production, development.
• Analytical Program, Review of Reports and Certificates of Analysis, administration of CAPA's.
• Laboratory analysis of MP, PT and stabilities.
• Validations of Analytical Methods.Schedule stability analysis, MP for production, development. • Analytical Program, Review of Reports and Certificates of Analysis, administration of CAPA's. • Laboratory analysis of MP, PT and stabilities. • Validations of Analytical Methods.

Skills: Supervisory SkillsSkills: Supervisory

Computer Systems Validation Specialist

GxP COMPLIANCE · Full-timeGxP COMPLIANCE · Full-timeJan 2020 - Jul 2020

Identify and qualify all computer systems which impact cGMP operations using a risk based methodology
Drive the development of system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are met
Schedule and execute validation plans and tests managing the execution by others where necessary
Develop and maintain:
Validation SOP’s
Validation plans
Requirements
Risk Assessments
IQ/OQ protocols, tests plans, scripts and reports
All other deliverables within the scope of the validation plan
Evaluate proposed changes to validated computer systems and recommend level of validation activities required
Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents
Communicate with the cross functional teams in a constructive, thoughtful manner to achieve validation objectivesIdentify and qualify all computer systems which impact cGMP operations using a risk based methodology Drive the development of system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are met Schedule and execute validation plans and tests managing the execution by others where necessary Develop and maintain: Validation SOP’s Validation plans Requirements Risk Assessments IQ/OQ protocols, tests plans, scripts and reports All other deliverables within the scope of the validation plan Evaluate proposed changes to validated computer systems and recommend level of validation activities required Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents Communicate with the cross functional teams in a constructive, thoughtful manner to achieve validation objectives

Skills: Validation

Quality Control Chemist

Probiomed Feb 2016 - May 2017

Analyze lab test findings to monitor quality and provide reports for biotechnology industry.
Accomplishment:
Successful in the development of new protocols and operating methods that reduced testing times.
Analyze lab test findings to monitor quality and provide reports for biotechnology industry. Accomplishment: Successful in the development of new protocols and operating methods that reduced testing times.

Skills: Biotechnology · Molecular BiologySkills: Biotechnology · Molecular Biology

Quality Assurance Coordinator

Probiomed  Feb 2016 - Feb 2017

• Review and approve of finished product to ensure compliance with regulatory standards and approved processes.
• Assist with Risk Assessment Process to support the business.
• Working collaboratively with colleagues to ensure thorough investigations, the determination of root cause, and appropriate Corrective and Preventative Actions.
• The timely assessment and closure of all issues and CAPA.
Accomplishment:
Successful in keeping up to date documents such as SOPs, procedures, methods, protocols, CAPA´s that were years behind.
 

Centro de Investigación y de Estudios Avanzados del IPNCentro de Investigación y de Estudios Avanzados del IPN

Master's degree, BiotechnologyMaster's degree, Biotechnology 2017 - 2019

Instituto Politécnico NacionalInstituto Politécnico Nacional

Bachelor's degree, BiotechnologyBachelor's degree, Biotechnology 2009 - 2013