Ana Karen Garcia Roa

General Directorate of Competitiveness and Competition.
Data Laboratory.
Responsibilities: Specialized technical advice

• Responsibilities: Coordinate and supervise the documentary system of the quality control laboratory, updating of methods of analysis, development and updating of standard operating procedures.
• Training and qualification of quality control personnel, control and ordering of laboratory supplies.
• Review of documentation generated from validations and transfer of analytical methods.
• Administration of retention samples of finished product and raw material.
  Attention to internal and external audits.
  Management of personnel in charge.

• Documentary system coordinator, control of master documents (SOPs, work instructions, manufacturing records, verification reports, etc.) controlled documents.
• Coordinate and supervise the update and generation of analytical monographs and methods of analysis, review of
  analytical monographs and methods of analysis, review of national and international pharmacopoeias.
  
• Organize and review technical information for modifications, elaborate technical justifications for responses to COFEPRIS.

Development and updating of analytical monographs of raw material, bulk product and finished product according to current Pharmacopoeias.
Periodic review of national and international Pharmacopoeia updates.

Finished product analysis, transfer of analytical methods, development, updating and training of standard operating procedures, reception, administration and storage of reference substances.