Summary
Overview
Work History
Education
Skills
Additional Formations And Interests
Timeline
Generic
Ana Celina Angel Estepa

Ana Celina Angel Estepa

Pharmacist
Mexico, México

Summary

Responsible and dynamic person, with very good interpersonal relationships, ease of adaptation, teamwork, leadership, and problem solving. One of my greatest motivations is constant learning, which has led to my professional career, a great advantage inso extent that I pay special interest to change and improvement of the activities, processes, or projects in which I have participated. I have extensive experience in quality processes and manufacture of sterile and non-sterile medicines. I currently serve as Quality Operations Head. Wide experience in quality compliance and GMP certifications based on local and regional regulations (INVIMA, ANVISA, DIGEMID, ANMAT). Good experience in regulatory compliance and dossiers submission to obtain market authorizations. Good skills to leader teams, strong problem solving capabilities, empower collaborators and to accept new challenges, great sense of responsibility and, development of plans with specific objectives.

Operations professional with track record of optimizing processes and enhancing productivity in dynamic environments. Known for fostering team collaboration and consistently achieving results. Reliable and adaptable, bringing expertise in project management and process improvement.

Overview

25
25
years of professional experience
4
4
years of post-secondary education
2
2
Languages

Work History

Site Quality Operations Head

SANOFI PASTEUR
08.2023 - Current
  • Company Overview: BIOPHARMACEUTICAL Sector - Vaccines
  • Develop and oversee the implementation of the site quality roadmap in line with the site and global strategies.
  • Ensure that all activities in both sites (antigens and FF&P) are executed in compliance with applicable regulatory requirements, leading the sites quality management system.
  • Lead and manage quality team assuring professional development.
  • BIOPHARMACEUTICAL Sector - Vaccines
  • Quality Team Consolidation and Development assuring mutualization in some process for both sites.
  • Quality Control Lab Productivity Improvements.
  • Compliance with Budget Assigned to the area.
  • Improvement in global audits result.
  • Strengthening key programs for the sites such as Data integrity and sterility assurance.

Quality Management Manager

SANOFI AVENTIS DE COLOMBIA
08.2017 - 07.2023
  • Company Overview: PHARMACEUTICAL Sector
  • Ensure that all processes to manage quality are implemented and maintained, through the local application of corporate guidelines.
  • Ensure correct anticipation and scaling of the resources necessary for quality management.
  • Ensure regulatory and regulatory compliance at all levels of the plant, in such a way as to ensure the maintenance of certifications in good manufacturing practices obtained before ministries of health at national and international level.
  • Constantly look for opportunities for process improvement across the value chain.
  • PHARMACEUTICAL Sector
  • Three Global Audits without critical findings.
  • ANVISA-2018 Recertification.
  • GMP DIGEMID-2018 Certification.
  • Quality Team Consolidation and Development.
  • Quality Control Lab Productivity Improvements.
  • Compliance with Budget Assigned to the area and key projects for the site related with simplification and performance improvement.
  • Strengthening key programs for the site such as Data integrity and Risk Management.
  • ICHQ3D project implementation at site level according to global strategy.
  • Participation as part of the team responsible of culture change project.

Quality Assurance Chief

SANOFI AVENTIS DE COLOMBIA
02.2016 - 07.2017
  • Company Overview: PHARMACEUTICAL Sector
  • Maintain the Quality Management System, complying with the guidelines established in the Site Quality Guarantee Program.
  • Ensure proper compliance and application of BPM in the plant.
  • Implement on-site policies delivered by parent company, performing their correct reading, interpretation, and documentation on local documents.
  • Closure of technical gaps associated with the BPM certifications of the plant.
  • PHARMACEUTICAL Sector
  • GMP recertification and GLP-2017 certification.
  • ANVISA-2016 certification.
  • Application of self-inspection processes applying corporate tools.
  • Improved tool for the execution of quality research.

Technical director (Qualified person)

SUPPLA S.A.
10.2013 - 02.2016
  • Company Overview: LOGISTIC PHARMACEUTICAL Sector
  • Lead the functions of the Technical Area related to regulatory entities (INVIMA).
  • Assure GMP certification in different operations for products such as: Drug product, Cosmetics, Toilet & Cleaning, Medical Devices.
  • Attention to GMP audits from customer’s headquarters.
  • Cold Chain assurance (Good storage practices).
  • Lead the company's improvement plans for the management of the Packaging, Storage and Distribution of Products.
  • LOGISTIC PHARMACEUTICAL Sector
  • Implementation of risk analysis system in secondary packaging and storage processes.
  • Strengthening the quality system, leveraged in the fulfillment of customer requirements.

Quality Assurance Manager

VITROFARMA S.A.
02.2010 - 10.2013
  • Company Overview: PHARMACEUTICAL Sector
  • Manage the Quality Management System of the six plants that made up the company, leading a team of professionals who ensured the implementation of good manufacturing practices in each processes executed.
  • Lead GMP certification processes of the different plants by regulatory entities.
  • PHARMACEUTICAL Sector
  • Obtaining GMP certification with INVIMA and ICA in the different audited plants, for reasons such as: Capacity increase, Plant expansions and new plants.
  • Structuring a robust Metrology and Validation Area capable of supporting all plants.
  • Successful participation in projects developed by the company related to the Design and Construction and Updating of Pharmaceutical Plants.

Technical and Production Director

ALEMAN HOMEOPATIC LABORATORY
11.2003 - 01.2010
  • Company Overview: PHARMACEUTICAL SECTOR
  • Development of production programming.
  • Production compliance check.
  • Preparation of Documentation related to the Production process.
  • Approval of the technical documentation of the company.
  • Preparation of Dossier to request health records of sale before INVIMA and ICA.
  • To respond in a timely manner to requests from regulatory bodies such as INVIMA and ICA.
  • PHARMACEUTICAL SECTOR
  • GMP certifications by regulatory entities INVIMA and ICA.
  • Obtaining Certification in Quality Management System based on ISO.
  • Increased production capacity of the plant, through the design and construction of a new production plant with operating flows according to liquid, solid and semi-solid pharmaceutical forms.

Production chief

QUALITY PHARMACEUTICAL SERVICES
09.2002 - 08.2003
  • Company Overview: VETERINARY Sector
  • Develop the production program and its implementation.
  • Develop and review technical documentation related to the Production process.
  • VETERINARY Sector
  • Compliance with production programs designed to meet the needs of the customer, as well as internal ones.
  • Decrease in production declines.

Quality Assurance chief

RIOSOL LABORATORIES
03.2002 - 08.2002
  • Company Overview: PHARMACEUTICAL Sector
  • Develop and implement the plant's quality guarantee program.
  • PHARMACEUTICAL Sector
  • Obtaining BPM Certification with INVIMA.
  • Improved production processes and implementation of in-process controls.

Quality Control Chief

Roberto Pineda LTDA LABORATORIES
02.2000 - 02.2002
  • Company Overview: PHARMACEUTICAL Sector
  • Sample and analyze materials, product in process and finished product.
  • Execute inspections on manufacturing lines.
  • PHARMACEUTICAL Sector
  • Obtaining BPM certification of the plant before INVIMA.
  • Compliance with management indicators in terms of analysis times.

Education

Top Management Specialist -

Universidad del Valle
01.2021 - Current

Pharmacist Title - undefined

Universidad Nacional de Colombia

Bachelor's degree - undefined

Colegio San José

Skills

Additional Formations And Interests

  • Strengthening Women Leadership, 03/2022
  • GLD- Inclusive Leadership Workshop, 10/2021
  • LD- Insights Personality Discovery, 05/2021
  • GLD- Challenge your Bias, 04/2021
  • GMP Implementation for non-steriles products, 09/2020
  • Development the team and its Culture, 09/2020
  • GLD-Leadership Essentials, 09/2020
  • Data Integrity Advanced Investigation Techniques, 04/2020
  • Risk Management / Risk Profile, 03/2020
  • Sanofi Manufacturing System- Lean initiatives, 01/2020
  • Inspection Management and responses handbook, 07/2019

Timeline

Site Quality Operations Head

SANOFI PASTEUR
08.2023 - Current

Top Management Specialist -

Universidad del Valle
01.2021 - Current

Quality Management Manager

SANOFI AVENTIS DE COLOMBIA
08.2017 - 07.2023

Quality Assurance Chief

SANOFI AVENTIS DE COLOMBIA
02.2016 - 07.2017

Technical director (Qualified person)

SUPPLA S.A.
10.2013 - 02.2016

Quality Assurance Manager

VITROFARMA S.A.
02.2010 - 10.2013

Technical and Production Director

ALEMAN HOMEOPATIC LABORATORY
11.2003 - 01.2010

Production chief

QUALITY PHARMACEUTICAL SERVICES
09.2002 - 08.2003

Quality Assurance chief

RIOSOL LABORATORIES
03.2002 - 08.2002

Quality Control Chief

Roberto Pineda LTDA LABORATORIES
02.2000 - 02.2002

Pharmacist Title - undefined

Universidad Nacional de Colombia

Bachelor's degree - undefined

Colegio San José
Ana Celina Angel EstepaPharmacist