Jessica Ortiz Gutierrez
CDMX
Summary
Detail-oriented team collaborator with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of passion.
Overview
4
4
years of professional experience
Work History
Product Quality Specialist
Boehringer Ingelheim
01.2023 - Current
- Product quality assurance through quality management systems.
- Responsible for management and review of Change controls, Annual Product Review, Complaints, Deviations, Events, CAPA applicable to the product.
- Quality assurance in packaging and manufacturing processes.
- Review of manufacturing and packaging records.
GMP Specialist
Boehringer Ingelheim
12.2021 - 12.2022
- Administration of the Annual Product Review system as a local Management System Owner.
Issuance of APR/PQR reports for products marketed nationally and internationally. - Facilitated the obtaining of information for the issuance of annual product reports.
- Support for local system administrator of Change Controls by the management of change controls committee, user support and training.
- Participation and support in external and internal audits covering quality systems.
- Obtaining performance indicators (KPIs) for the Annual Product Review and Change Control systems.
CMC Documentation Specialist
Boehringer Ingelheim
03.2021 - 12.2021
- Coordination and management the CMC (Chemical, Manufacturing and Control) technical documentation required submission in worldwide ministries of health, according to ICH and GXP (Good Practices) for human and animal health products.
- Management and archived master documentation.
- Management changes with regulatory impact for products in compliance with national and international requirements.
- Archiving specifications for analysis of raw materials and finished products related to human and animal health.
Documentation Trainee
Boehringer Ingelheim
07.2020 - 03.2021
- Management of training system through the management of users and training and qualification items.
- Management of documentation system to carry out control and registration of users and implementation of local and corporate procedures.
- Local support for users through direct contact and coordination of internal and external courses.
Education
Bachelor of Science - Biological And Pharmaceutical Chemist
Universidad Nacional Autónoma De México
CDMX12.2019
Skills
- Management collaboration
- Analytical Thinking
- Project Planning
- Quality Assurance
- Documentation Management
- Data Analysis
- Friendly, Positive Attitude
- Flexible and Adaptable
Additional Information
Annual Product Review Certificate by Terrafarma Group.
Languages
English
Upper intermediate (B2)
Timeline
Product Quality Specialist
Boehringer Ingelheim
01.2023 - Current
GMP Specialist
Boehringer Ingelheim
12.2021 - 12.2022
CMC Documentation Specialist
Boehringer Ingelheim
03.2021 - 12.2021
Documentation Trainee
Boehringer Ingelheim
07.2020 - 03.2021
Bachelor of Science - Biological And Pharmaceutical Chemist
Universidad Nacional Autónoma De México
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