Experience

Pampamed SRL

• Argentina
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Assurance Sr. Specialist (Phamacist)/PRRC Back up

  • Mar 2022 - Present

  >Support in the tasks related to the Product Registration, Regulatory Affairs & Quality Assurance ISO 13485 (including audit processes).>Ensuring the authorization licenses activities are maintained.>Responsible for ensuring document accuracy of information submitted before the Health Authority. >Contact with Competent Authority for the imported, manufactured and distributed activities.>Maintenance of Quality Management System (QMS) and its adequacy to the current regulations (SOPs, WI).>Risk management. >Management of complaints and CAPAs, including contact with surgical technicians, doctors and patients. >Identification of potential nonconformities and improvement opportunities. >Creation of the Internal/ External Audits and the Audit Program for suppliers and its implementation. >Change control. >Verification and product release.>Training programs. >Proposition of initiatives in order to improve QM, evaluate and analyze quality indicators, data and performance metrics. >Communication with the I+D departament to improve devices because of client's feedback. >Support quality and health inspections. >Check the timely and correct identification and disposal of the product returned by customers, quarantine and non-complaint. >Regulatory affairs: evaluate documents, do submissions and the follow-up of registrations files for initial submission, renewals and variations in the local and foreign market (USA, CE). Follow up and communicate to commercial teams about regulatory status and registration progress. Manage the regulatory requirements for local and foreing medical devices labeling.



Asoprofarma Cooperativa de Provisión Limitada

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Technical Director/PRRC

  • Apr 2017 - Feb 2022

  >Daily verification of GDP (Good Distribution Practices) of medical devices and pharmaceutical products. >Health Authority ́s Relationship (Ministerio de Salud, ANMAT).>Health inspections. >Updating the guidelines, regulations and policies related to warehouse and distribution of pharmaceutical products. >QMS Responsable: SOPs, WI, Training, Supplier assurance. >Plan, coordination and execution of the strategies and activities related to calibration, qualification and validation of GxP instruments, equipment, critical systems, procedures and computerized systems in accordance with local standards. >Writing protocols related to mapping warehouse temperatures and to cold chain validation. >Establishing and timely verifying the execution of all the CAPAs. >Change control. >Proposition of initiatives in order to improve QMS, evaluate and analyze quality indicators, data and performance metrics. >Collaboration in the execution of tasks related to the administration of computerized systems in collaboration with the system´s owner. >Ensuring that all GxP computerized systems are installed and managed in accordance to local regulations, also ensuring that all applicable users have access to these systems with appropriate permissions. >Collaboration with system teams to ensure validations of computerized systems.>Creation of quality contracts for transportation service providers and ensure our compliance, internal Audits related to QA (Quality assurance), Data integrity and local regulations.>Risk management. >Ensuring the preventive-corrective maintenance activities, Recalls. >Interactions with other sectors. >Personal in charge. >Regulatory affairs.

• Technical Director assistant

  • Nov 2015 - Mar 2017

  >Supplier assurance.>Regulatory affairs.



SAFYBI - Asociación Argentina de Farmacia y Bioquímica Industrial

• Argentina
• Non-profit Organizations
• 1 - 100 Employee

• Member of Warehouse and Distribution of pharmaceutical products committee.

  • Jun 2021 - Dec 2021

  >Design and coordinate training programs to another collegues who work in supply chain. >Design and coordinate training programs to another collegues who work in supply chain.



Deplamed SRL

• Regulatory affairs Coordinator and QMS Responsable

  • Mar 2013 - Oct 2015

  >ISO 9001: Participation in ISO 9001´s certification, SOPs, WI.>Training programs.>Updating the guidelines, regulations and policies related to manufacturing of pharmaceutical products.>Plan, coordination and execution of the strategies and activities related to calibration, qualification and validation of GxP instruments, equipment in accordance with local standards. >Establishing and timely verifying the execution of all the CAPAs.>Change control.>Proposition of initiatives in order to improve QMS, Internal and external related to QA and local regulations.>Risk management. >Ensuring the preventive-corrective maintenance activities.>Interactions with other sectors.>Regulatory affairs: evaluate documents, do submissions and the follow-up of registrations files for initial submission, renewals and variations.