Experience

iVascular

• Germany
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Quality Assurance Technician

  • Mar 2020 - Present

  Manufacture of medical devices according to MDR, MDSAP and ISO13485. Quality Management System activities: - Document System Management. - Change Control System Management. - Internal Training Management. - Non-Conformities. - Audits (internal and external). - Calibrations - Suppliers evaluation. - Validations. - Wharehouse conditions Management. - Cleanroom controlled enviroment. Manufacture of medical devices according to MDR, MDSAP and ISO13485. Quality Management System activities: - Document System Management. - Change Control System Management. - Internal Training Management. - Non-Conformities. - Audits (internal and external). - Calibrations - Suppliers evaluation. - Validations. - Wharehouse conditions Management. - Cleanroom controlled enviroment.



Eurofins

• Luxembourg
• Biotechnology Research
• 700 & Above Employee

• • Oct 2018 - Mar 2020

  Quality controls testing according to GMP, EP, USP, UNE-EN ISO/IEC 17025 and audited by the FDA.Team Leader of the Facility Services Department (responsible of the management, coordination, and counselling to customers.- Purified water and steam systems.- Cleanrooms environment.- Cleaning validations.- Gas and compressed air systems.- Non-viable particle levels.

• • Jun 2018 - Oct 2018

  Quality controls testing according to GMP, EP, USP, UNE-EN ISO/IEC 17025 and audited by the FDA.Quality Assurance Department:- Controlled copies management.- Maintenance of the Quality Assurance archive.- Supplier qualification.- Support in the management and follow-up of CAPA's and Change Controls.- Preparation of monthly quality reports.- Support in internal audits.- Follow-up of GMP employee training.Quality Control Department- Coordinator of environmental microbiological monitoring of clients:- Management and review of data generated in environmental monitoring of customers.- Management and review of data generated in internal environmental monitoring. Show less

• • Oct 2016 - May 2018

  Quality controls testing according to GMP, EP, USP, UNE-EN ISO/IEC 17025 and audited by the FDA.Coordinator of environmental microbiological monitoring for clients:- Management and review of data generated in environmental monitoring of clients.- Management and review of data generated in internal environmental monitoring.Quality controls testing:- Challenge test: evaluation of the preservative system in cosmetics and pharmaceutical products.- Evaluation and qualification of disinfectants. EN13697; EN13727/EN13624; EN1276/EN1650; EN1040/EN1275; EN13704; EN14561; EN14562; EN16615- Antibiotic potency by agar diffusion.- MICs (Minimum Inhibitory Concentration)- Bioburden of pharmaceutical, cosmetic and medical devices products.- Validation of microbiological analysis methods.- Environmental monitoring of pharmaceutical companies.- Purified water testing. Show less

• • May 2014 - Oct 2016

  Quality controls testing according to GMP, EP, USP, UNE-EN ISO/IEC 17025 and audited by the FDA.Quality controls testing:- Challenge test: evaluation of preservative system in cosmetics and pharmaceuticals.- Evaluation and qualification of disinfectants. EN13697; EN13727/EN13624; EN1276/EN1650; EN1040/EN1275; EN13704; EN14561; EN14562; EN16615- Antibiotic potency by agar diffusion.- MICs (Minimum Inhibitory Concentration)- Bioburden of pharmaceutical, cosmetic and healthcare products.- Validation of microbiological analysis methods.- Environmental monitoring of pharmaceutical companies.- Irritation test in in vitro cultures. Show less

• • Nov 2013 - Apr 2014

  Quality controls testing according to GMP, EP, USP, UNE-EN ISO/IEC 17025.Practicum and final Master's project:- "Método rápido para la evaluación de eficacia de desinfectantes frente a biofilm" (EN 13697)



PharmaMar

• Spain
• Biotechnology Research
• 300 - 400 Employee

• QC Laboratory Supervisor

  • Feb 2016 - May 2018

  Professional Scientific Services (PSS), Eurofins Biopharma Product Testing Spain S.L.U. project. Supervision and microbiological quality control testing: - Environmental monitoring. - Purified water monitoring and testing. - Endotoxin detection by Gel-Clot. - Microbiological analysis of pharmaceutical products (APIs and intermediates). - Validation of methods for products under development. - Preparation of protocols and validation reports and procedures. Backup of subcontracted Eurofins Biopharma Product Testing Spain S.L.U. personnel at PharmaMar's facilities. Show less



Applus Norcontrol

• Spain
• Oil and Gas
• 400 - 500 Employee

• Student Employee

  • Oct 2012 - Feb 2013

  Practicum of bachelor's degree: - Preparation of culture media. - Preparation of agri-food/cosmetic samples. - Daily checking of laboratory equipment. Practicum of bachelor's degree: - Preparation of culture media. - Preparation of agri-food/cosmetic samples. - Daily checking of laboratory equipment.