Experience

Neuraxpharm

• Spain
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• QA Tech. Transfer Specialist

  • Sep 2022 - Present



Eurofins Biopharma Product Testing Spain

• Spain
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• • Sep 2020 - Sep 2022

  Adding to the previous responsibilities: Adding to the previous responsibilities: INTERNAL AUDIT: .- Management and performing of self-inspections/internal audits based on the previously elaborated Risk Analysis. Generate and review shreds of evidence, prepare a preliminary and final audit report..- Elaborate a Finding Report and follow the status of the CAPA plan CLIENT AUDIT.- Deal and schedule the customer audits and prepare the previous documentation requested by them (current certificates and Statements etc.). Receive the Audit Agenda and review the previous Finding Report (if applicable) to ensure all actions (the status of CAPA plan) has been closed. .- Participate in Client Audits as an auditor:* Initial meeting: Introduction, audit objective, auditee presentation* Facilities tour: quality control laboratory, critical systems (e.g. purified water system, HVAC for the microbiological area, etc.), * Documentation review: prepare for audit/assessments by researching documentation requested by the client (Quality System Management, records, and procedures, data integrity procedures (roles, data recording), spreadsheet management, etc.* Closing meeting .- Receive and review the Audit Report sent by the client to elaborate on a Finding Report due to deviations. After, generate all corrective and preventive actions (if necessary) and follow the status..- Perform the UNE-EN ISO/IEC 17025:2017 audit by ENAC in our facilities and international Pharmaceutical Industries. Show less

• • Dec 2019 - Sep 2022

  Pharmaceutical laboratory with GMP and GLP certifications, ISO-17025 accreditations, and FDA certified. .- Manage the tracking, reporting, and adequacy of actions, verification, closeout, and trending of all corrective and preventive actions of all internal and client audits performed (CAPA plan). .- Handle Change Control requests as assigned, initiating and routing internal change control requests for evaluations and/or approval, and monitoring the progress of related action items. .- Participate in Client Audits as auditor, preparing for audits/assessments by researching documentation requested by clients, the status of previous CAPA plan, etc. .- Management of self-inspections/internal audits based on the previous elaborated Risk Analysis. .- Co-ordination of Exceptions (Investigations OOS, OOT, Planned Deviation, etc.) in the LIMS system. Level approval as Critical, Major, or Minor and send to the client the generated report. .- Trainer of new employees according to Quality Assurance Department modules as LIMS formation, EtQ formation, and Data Integrity Formation. .- Review, check and approve IQ, OQ, PQ, and Validated Excel Spreadsheets reports generated by Metrology Department. .- Keeping up the supplier qualification based on their certifications/accreditations and execute Supplier Audits depend on previous Risk Analysis Show less



Almirall

• Spain
• Pharmaceutical Manufacturing
• 700 & Above Employee

• • Aug 2018 - Jul 2019

  - Formulación, desarrollo y fabricación de formulaciones sólidas y semisólidas. Conocimiento de los diferentes procesos, así como de los equipos. (Reactores becomix, agitadores IKA, compresoras Korsch PH-106, XP-1, Bonals)- Funciones de calidad: participación directa en los procesos de cualificación (PQ, OQ), elaboración de informes de calidad, de producto (SOP’s), no conformidades (OOS), soporte en la elaboración de PQR, Sistema de gestión de información de laboratorio (LIMS) y ELN.- Conocimiento y aplicación de la normativa GMP. Elaboración de guías de fabricación GMP para Ensayos Clínicos y Non- GMP para lotes I+D. (Manufacturing Execution System). Show less

• • Feb 2018 - Aug 2018

• • Oct 2017 - Feb 2018

  - Manufacturing Execution System (MES)- Ensure that the implementation of the new module called Compose & Capture(BIOVIA) by the formulation department integrated into the electronic Lab-notebook is correct.- Create and execute UAT (User Acceptance Test)- Responsible for creating SOPs (standard operating procedures) for the use of the system. Be responsible for generating training materials.



Universitat de Barcelona

• Spain
• Research Services
• 700 & Above Employee

• Research

  • Jan 2017 - Sep 2017

  .- Design and synthesis of new compounds possessing heterocyclic nucleus and potential anti-tumor and anti-inflammatory activities through the inhibition of IL-17 targets. Each compound has been characterized by NMR-1H spectra and thus can confirm the expected structure. .- Purification of compounds prepared using methods Chromatographic (column chromatography, HPLC), recrystallizations, microdestilations in reduced pressure, and structural characterization using spectroscopic techniques (IR, NMR of 1H and 13C NMR), mass spectrometry, melting point and elemental analysis. .- Familiarization with the equipment, material and conventional techniques of a laboratory of organic chemistry. Show less



Farmacia Lda. Nuria Brun

• Molins de Rei

• Junior Pharmacist

  • Jun 2016 - Jan 2017