Francisco Simael Cedeño Ramos Email & Phone Number

Mexico City, Mexico

Naucalpan De Juárez, México, México

Naucalpan De Juárez, México, México

CDMX

Lerma, México, México

• Management of the following areas:
• Quality Assurance (in process control, inspection, sampling, finisht product and raw materials release)
• Quality Systems and Documentation (CAPAs, deviations, change control and effectiveness check management, APR, documentation).
• Regulatory Compliance (Dossiers elaboration, MoH prevention response)
• Audits (internal, external, GMP suppliers and regulatory)
• Budget Management

Naucalpan De Juárez, México, México

• Quality Systems Compliance (CAPA’s, Deviations, Change Controls, Effectiveness Checks, SOP’s)
• Audits Attendance (Regulatory, External, Internal Audits)
• Regulatory Compliance (dossiers elaboration, Regulatory Affairs support – local, regional and international)
• Complaints Management
• Raw Materials, Primary and Secondary Packaging, Bulks, and Finished Product Release
• Specifications and Analytical Methods Management

Ciudad De México Y Alrededores, México

• Specifications and Analytical Methods Management
• Physicochemical & Microbiological Laboratory, Purchased Materials, and Analytical Methods Validation Area
• Budget Management
• Personnel Management for KPI’s compliance (7 direct reports and 16 indirect reports)KEY CONTRIBUTIONS:
• Quality Systems Implementation in 2015-2016
• SAP QM Module Implementation in 2017

Coyoacán, Distrito Federal, México

• Active member of the Global Change Control Board. Technical reviewer and impact analysis for local and global Change Controls
• Out of Specifications Results Follow up and Investigation.
• Follow up and Closure of CAPA’s
• Analytical Method Validations and Transferences.
• Cephalosporine and non-Cephalosporine Laboratories Management,
• Budget ManagementKey Contributions

Coyoacan, DF

• Critical systems committee coordination
• Follow up for OOS Investigations
• Follow up and closure of CAPAs
• Microbiological Method Validation
• Microbiological laboratory management
• Budget ManagementKEY CONTRIBUTIONS:

Coyoacán, DF

• Quality Supervision for maintenance and engineering areas
• GMP Service Providers Supervision
• Quality Leader Auditor
• Follow up and monitoring of CAPAs, effectiveness checks, change controls and deviations
• Active member of risk management group
• Areas, equipment and critical systems release

Coyoacán, DF

• Equipment qualification
• Computer Systems Validation
• Equipment and Instruments Maintenance/Calibration Coordination
• Deviation Leader Investigator with RCA methodology
• Change Contro OwnerKEY CONTRIBUTIONS
• Laboratory Equipment Migration to New QC Laboratory without impact in company operations in 2007

Coyoacán, DF

• Finished Product, In-process product, raw materials analysis
• SOP ElaborationKEY CONTRIBUTIONS
• Analytical Method Transferences from Corporate to Mexico

Pharmaceutical Administration Diploma, Farmacia, Ciencias Farmacéuticas, Farmacología Y Administración

Qfb, Química Médica Y Farmacéutica