Gerente de aseguramiento de calidad

Gon*** ***** (XX años)
QUALITY ASSURANCE HEAD en ROCHE PHARMACEUTICAL
Escuela Nacional de Ciencias Biológicas, IPN
Toluca,
Estado de México
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Experiencia
QUALITY ASSURANCE HEAD
ROCHE PHARMACEUTICAL
oct 2017 - jul 2020
Responsible for: Management of the quality assurance operation at the distribution center (commercial, psychotropic & clinical products) for Mexico affiliate in order to be a strategic partner for the commercial area (product availability at the market for current and new launches products). Accountable for GMPS´s in warehouse and Quality oversight of 3PL in order to comply with local regulatory (e.g. NOM 059) and global Roche policies and standards. Lead Quality & Regulatory Audits (Ministry of Health, internal & corporate audits). Manage the team through screening, training, monitoring performance. Drive talent acquisition, retention, and development for the quality team. Establishes strategies in conjunction with fellow business leaders, leading cross-functional teams to ensure achievement of business objectives, complete projects, address quality issues, and implement quality system improvements.
QUALITY COORDINATOR
ROCHE DIAGNOSTICS
oct 2009 - oct 2017
Responsible for: Management Quality System, Diagnostics Division (deviations, CAPAS, complaint, recall, KPI´s). Quality oversight of quality programs in the warehouses (BPAD, ISO 13485, Cold Chain). Approval of the areas and transport qualification at the Warehouse (includes protocols and reports) to assure the Cold Chain. Lead Quality audits (ISO 9001:2008, Supply Chain, Corporate, and Business).
QUALITY SYSTEM LEAD AUDITOR
PEPSICO INTERNATIONAL
jul 2004 - sep 2008
Responsible for: Coordination and execution of Quality Systems audits within “Sabrita’s model” for the complete manufacturing net within the company & Training in Quality and Safety programs.
QUALITY HEAD
PEPSICO INTERNATIONAL
jul 2000 - sep 2004
Responsible for: Coordination and management of Quality Area (quality, resources, personnel, certification lines, training, projects) throughout the manufacturing value chain: raw materials, process, packing, warehouse. Raw materials inventory management (Potatoes, corn).
Formación
Biochemical Engineer
Escuela Nacional de Ciencias Biológicas, IPN
jul 1987 - jul 1992
Professional with knowledge for the life science industry or Health industries with strong technical skills in chemistry, biochemistry, food science & management personal 
Idiomas
English - Fluent