Quality Assurance Manager

• Sep 2022 - Present

Quality Assurance Specialist - Regulatory support

• Jan 2020 - Sep 2022

Jan 2020 - Present (2 years 8 months +) Medical Brands is a medical device company of OTC products as per vaginal infection tablets, fungal nail treatments, IBS capsules, wart treatment products, cough syrups and throat sprays, chicken pox treatment, corn treatments, and UTI capsules. We work with worldwide pharmaceutical distributors and requirements. Responsible of the following task: • Project management for transferring production to new supplier. • Method of analysis validations • Production validations • Equipment validations • Management of all Quality Assurance tasks: managing change controls, change control artwork, complaints evaluation and reporting, CAPAs, Non Conformity process, updating and creating new SOPs and Work Instructions, management of suppliers, audits (internal and external audit performance and follow up) • Training of new employees • ISO compliance (ISO 13485), GMP, GLD and MDR • Submission of products dossiers to the Notify Bodies. • R&D projects management: New projects development and validations • Laboratory analysis evaluation. • Stability testing evaluation. • Product Dossier submissions to competent authorities. • Risk analysis • AQL analysis • QMS according to MDR and ISO 13485 • Supplier management • Auditing (internal and external)

QC- supervisor -Biochemistry expert

• Dec 2017 - Jan 2020

Biochemistry supervisor in QC environment certified with ISO 17025, GLP/GMP, Main point of contact between production and QA. • QESH- Collaboration in the Validation Master Plan (writing SOPs & risk assessments) • Supervising a seven people team’s and sample release . • Statistical evaluations of results. • Work plans maker for improvements and solving troubles in analysis. • Calibrations of standards and control samples. • Author of certificates and method of analysis. • Validations of new methods and equipment. • Tiamo software: set up different programs for titrimetric assays and equipment qualification. • Quality investigation and CAPA. • Internal and external audits. • Researching.

Privated sciences teacher

• Dec 2012 - Jan 2020

Teaching statistic, maths, chemistry and physics Teaching statistic, maths, chemistry and physics

Key account Order Management Specialist and Sales Support Assistant for Spain and Portugal

• Dec 2015 - Nov 2017

Customer service and sales support assistant for Pharma Chemical products.Primary contact for Key Accounts in the Global Pharma Production division.Customer Relationship Management.Team leaderWeekly reports for Key Accounts.Guarantee the quality of the supply chain in contact with Customers, Sales and Logistics.Support for Regulatory Affairs team.Monitoring delivery times to ensure they are on time.Manage of SAP with order entries and Sales Force for quotes creations. Work supporting Account Managers and closely with Product Managers. Manage a high-volume workload within a deadline-driven environment.Sales support assistant for Spain and Portugal providing certificates and statements, and escalating technical and regulatory questions. Sales Force order management and quote creation. Work together with Account Managers to create CSP for our Key Accounts customers.

Credit and management

• Jun 2015 - Dec 2015

Working independently with the Project about the new system of electronic invoices for Spain.Management of FACE system, and different electronic invoice's system for Cataluna, Pais Vasco, Andalucia and Galicia.Customer relation-ship management.Work closely with the collection with the credit Spanish team.

Sales Assistant

• May 2014 - May 2015

Quality control

• May 2013 - Oct 2013

Position: Chemist - Quality control department Quality control analysis of product samples, trying the samples and checking that the main components still in perfect conditions. Take care of the complaint and analyze them. Responsible for writing reports for international customers about the defective samples for internal usage, and of the analysis of the defective sample to the customer. Interpret the research findings and draw conclusions, based on research reports Position: Chemist - Quality control department Quality control analysis of product samples, trying the samples and checking that the main components still in perfect conditions. Take care of the complaint and analyze them. Responsible for writing reports for international customers about the defective samples for internal usage, and of the analysis of the defective sample to the customer. Interpret the research findings and draw conclusions, based on research reports

Sales Assistant

• Feb 2013 - Jul 2013

• Customer service. • Replenishing. • Unloading and organizing new products. • Cleaning. • Customer service. • Replenishing. • Unloading and organizing new products. • Cleaning.

Production Control Analyst

• Jun 2011 - Jan 2012

Position: Chemist annalist, production control. Carry out the analytical methods of dissolution, distillation, filtration and gravimetry to ensure a thorough analysis of the samples Colour in solution (ICUMSA color) ,Polarization in Raw Sugar ,Conductivity, Sulphated and sulphite.. Undertake the responsibility of procuring and maintaining the required instruments in laboratory Training interns on chemical research procedures and the related risks. Verify the proceedings of the research activities with the predicted charts. Note down the deviations and work on it. Quality control of the wastewater(solids, pH, dissolved oxygen like SO4−2,NO−3 , chlorine…) Producing new reagents. Inventory control of the chemical products, forecast usage and base quantity ordering on it.

Research nanostructured materials assistant

• Sep 2010 - Sep 2011

Research group based in the University of Cádiz focused on the application of electron microscopy to the research field of nanostructured materials, with special emphasis on nanoparticulated systems and Catalysis. Research group based in the University of Cádiz focused on the application of electron microscopy to the research field of nanostructured materials, with special emphasis on nanoparticulated systems and Catalysis.