Velia López

Velia López

BUENAS PRÁCTICAS DE LABORATORIO

 

More that 30 years in the Pharmaceutical Industry in Quality areas as Quality control, Quality assurance, Quality operation, Regulatory in the plant, knowledge of the different Regulation for exportation product Latin America, EUDREX, Pharmaceutical responsible.

Participation in International forums, Expositor in local forums.

Experience in European (Sanofi-Aventis) and American (Wyeth/Pfizer) Companies.

Good audit performance in GMP certificate with Brazil, Colombia, Argentina, Peru, South Africa, Kenya, Ukraine, Saudi Arabia, Russia. ISO 9001 certification.

Good results in saving Quality program.

Building high performance develop people.

Experience in transferring and closing sites.

Contribution in evaluation of new or enlargement area/site

Major achievements:

  • Implementation of the Quality Assurance area and the Validation Department in Roussel.
  • I was involved in the design and qualification of the Solid, Injectable, Cephalosporin building and Distribution Center in Ocoyoacac.
  • To obtain recognition from Mexico Health Ministry for good handle in the HMR regulatory process and it was used like as an example for the industry.
  • To have more suppliers validated due to be member of the GHVP. I was one of the founders members.
  • To obtain the ISO 9001-2001 certification.
  • To obtain certification from different BoH’s. For example ANVISA (Brazil), INVIMA (Colombia), ANMAT (Argentina).
  • Reorganization of the Quality Area, improving of the customer service and reducing analysis cycle time.
  • Savings for analysis reduction, previously approval from BoH.
  • To do external audit with suppliers and affiliates.
  • Negotiation related to GMP issues with BoH.
  • Participation in Quality topics during the mergers in order to conform the new organization.
  • Participation in different forums as invited expositor for Pharmaceutical Mexican associations (FM, PQF, CNQFB).
  • To maintain the Mexican BoH certification and to create good image of the site before them.
  • Transferring from Cuautitlán to Ocoyoacac process on time.

Wyeth/Pfizer:

  • Reorganization of the Quality Area in order to improve the service.
  • To reduce the Quality cycle time.
  • Enhance utilities for many quality issues due to lack of inversion.
  • Participation in restarting the customer service in Nutritional area due to the start up of a new dryer.
  • Participation in the remodeling of Micro and Chemical labs for both, Pharma and Nutritional.
  • To maintain re-certification in ISO 9001 and to initiate the preparation for ISO 22000 certification.
  • To obtain re-certification from ANVISA, (Brazil), ANVISA (Colombia)
  • To obtain approval for analysis reduction in Raw material and FG from BoH Pharma and internally for Nutritional.
  • Lean Lab implementation in Pharma, Consumer and Nutritional areas.
  • LIMS implementation in Pharma and Nutritional areas.
  • Recognition from the Corporation and Commercial area for contributing in Products launch in Pharma, Consumer and Nutritional.
  • Contribute to obtain the production record in Nutritional of 3.000 M pounds.

Sanofi-Aventis:

  • To obtain GMP certification with SAUMP (Ukraine), COFEPRIS (Mexico), ANVISA (Brazil), DIGEMID (Peru), INVIMA (Colombia), ANMAT (Argentina), Kenia, South Africa, Qatar (without audit), Russia (Ministry of Industry and Trade), KSA (King Saudi Arabia).
  • ISO 9001-2015 certification without observation.
  • Synergies between Textitlan and Ocoyoacac site with benefits in Cost reduction, process simplification, time release decreasing, time release.
  • Transferring Quality activities from Textitlan to Ocoyoacac.
  • Improve Quality system in the site.
  • Saving Quality initiatives.
  • Enhance audit performance.
  • Implement Quality Culture program.
  • Chemical and Micro Lab enlargement.
  • Lean laboratory implementation use of tool as Gemba, visual management.
  • Product transfer process from the purchase of products CHC including export process with Canada and Latin America.
  • Use of project tool for objectives in Quality.
  • Obtain GMP for simplification process in biologic product.