I am currently working at BCN Peptides as part of the Quality Assurance team, both as a Drug Product Qualified Person and as a Toxicologist. I also support the clinical trials department in all possible quality aspects.
I feel fortunate to be able to cover different areas of the pharmaceutical industry and to take on new challenges over the years.
- Evaluation of new APIs that are proposed to be produced in the company (OEL-PDE), considering the stablished containment for the personnel involve in the production of the API and considering also the cleaning validation policy of the company.
- Release of sterile drug substances and investigational drug product; release of analysis for drug products performed in the Pharmaceutical Control Lab in BCN Peptides; monitoring of sterile production and assure the compliance with the Annex 1 of GMP; elaboration of risk assessment for environmental controls, training for the employees (dress up, cleaning, disinfection and working in sterile area, including Media fill...).
- Elaboration of PQR (for APIs, for water system and for environmental control); management and drafting of SOP; management of deviations, change controls and out-of-specifications (OOS); Cleaning Validations; Disinfectant effectivity Validations; Computer System Validations; release of API; Coordination and participation in customer and regulatory GMP audits; Management of Corrective and Preventive Actions (CAPA); Qualification and management of suppliers (for raw data, external services and clinical trials); Support in clinical trials projects; Toxicological evaluation of APIs.
- Sagrat Cor servei de Salut Mental in Martorell, from April 2007 to March 2008 and from March 2012 to June 2012.
- Consorci Sanitari del Garraf, Hospital San Camil, weekend punctual supplies during 2010.
- Centre Penitenciari d’Homes de Barcelona from April 2008 to June 2008, and from November 2009 to November 2010.
- Sanitat Penitenciaria de la Direcció Generalde Recursos i Règim Penitenciari. ( Departament de Justícia), from August 2009 to February 2010.
- Consorci Sanitari del Garraf, Hospital San Antoni Abad from January 2009 to August 2009.
- Clínica Teknon de Barcelona from Setembre 2008 to Gener del 2009.
- Xarxa Sanitària i Social Santa Tecla from June to Setembre del 2008.
- Hospital de Barcelona from Novembre 2006 to April 2007 (punctual supplies).
- Farmàcia Saltó in Barcelona from September 2006 to February 2007.
- Farmàcia Bosch Castell in Vilafranca del Penedès from September 2005 to November 2006, and as an auxiliary since 2001.
- Hospital de la Santa Creu i de Sant Pau as an auxiliary in July 2005.
Class B