Tecnicos de laboratorio holanda

Mon*** ***** (XX años)
Quality & Regulatory Affairs Associate at Roche en Roche Chile Ltda
Universidad Central de Venezuela
Residente fuera de España
Este candidato esta dispuesto a trasladarse
|
Experiencia
Quality & Regulatory Affairs Associate at Roche
Roche Chile Ltda
ago 2017 - ene 2021
•	Lead corporate tool for risk management and define business continuity and recovery strategies in the face of social contingency and COVID-19 pandemic in order to resume business operations quickly and safely, with the least negative impact on the business.
•	Improve providers and distributors qualification.
•	Transition of the new version of ISO 9001: 2015.
•	Implement Quality / Regulatory projects or initiatives that allow optimization of internal processes.
•	Lead the global Quality audit with satisfactory results.
•	Support Logistics team to obtain a successful warehouse recertification.                                                                                                                                                       
•	Lead the development and implementation of Roche Business Continuity Plan (PHARMA & DIA) identifying critical business processes, defining and implementing continuity and disaster recovery strategies in order to maintain business continuity.
Regulatory Affairs, Quality and Compliance Manager
Productos Roche Venezuela
mar 2009 - jul 2017
•	Maintain transparent oversight of all regulatory and quality activities. Monitor the progress, status and timelines of submissions.
•	Ensure that the processes are implemented, maintained and are delivering their intended outputs.
•	Ensure that internal and external audits are properly carried out and that corrective action is taken.
•	Design and implement a supply chain´s best practice in the affiliate.
•	Lead the global compliance Audit with satisfactory results.
•	Establish compliance standards based on internal policies, implementing procedures such as Code of Conduct, competition law, Anti-Bribery & Corruption, 
        Stakeholder´s due diligence, health care´s compliance, based on local laws and regulations.
Regulatory affairs & Application specialist
Representaciones Orgal, S.A
ene 2008 - feb 2009
•	Scientific and marketing support for all the company Diagnostic technologies and systems (Biochemistry, Immunology, Molecular Diagnostics).
•	Train users and clients in the use of molecular biology equipment, as well as clinical equipment.
•	Solve scientific issues with special focus on molecular diagnostic techniques. Performing presentations to potential clients supporting the sales process.
Specialized Medical Technologist
Avilab Molecular Biology Laboratory
ene 2004 - jul 2007
•	Responsible for manipulation, analysis and results-based emission samples from hospitalized and outpatient cases in different areas such as hematology, blood chemistry, body fluid chemistry, serology and bacteriology.
•	Handling samples from inpatient and outpatient cases for detection of viral, bacterial and fungal pathogens, using techniques like the Polymerase Chain Reaction (PCR), real time PCR, reverse transcriptase PCR, multiplex PCR.
Formación
Medical Tecnologist
Universidad Central de Venezuela
ene 2004 - jul 2007

          
        
Idiomas
Ingles - Avanzado
Otros datos
Education
	Quality Management Postgraduate, Universidad Católica Andrés Bello, 2018.
	Marketing Management Diploma, CIAP-Universidad Católica Andrés Bello, 2012.